Recall archive / FDA device enforcement

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC M... — FDA record Z-2298-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A; h. CVC BUNDLE, Model Number: ECVC3235; i. CVC BUNDLE 16CM, Model Number: ECVC2335; j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B; k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B; l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460; m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A; n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001; o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A; p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200; q. CVC BUNDLE KIT OR, Model Number: ECVC2205; r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A; s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120; u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150; v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B; w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105; x. CVC HEART PACK, Model Number: ECVC7360; y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A; z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860; aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895; bb. CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315; cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310; dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555; ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286; ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A; gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A; hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525; jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850; kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A; ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300; mm. CVC KIT WITH CATHETER, Model Number: ECVC885; nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105; oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B; pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235; qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B; rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B; ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400; tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465; uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070; vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940; ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J; xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L; yy. DBD-CATH/ANGIO...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Classification: Class II
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 76,870 kits
Agency-reported status: Ongoing
Source record identifier: Z-2298-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ61099B, UPC Number: 019532711185; Model Number: DYNJ61099C, UPC Number: 019532726200. b. Model Number: DYNJ61118C, UPC Number: 019348946397; Model Number: DYNJ61118F, UPC Number: 019532726198. c. Model Number: DYNJ41649G, UPC Number: 019532727729. d. Model Number: ECVC2595, UPC Number: 10653160332596. e. Model Number: CDS984100U, UPC Number: 019532714613; Model Number: CDS984100V, UPC Number: 019532725205. f. Model Number: ECVC2225, UPC Number: 10653160334385. g. Model Number: ECVC7265A, UPC Number: 10653160345145. h. Model Number: ECVC3235, UPC Number: 10653160336112. i. Model Number: ECVC2335, UPC Number: 10653160332497. j. Model Number: ECVC5120B, UPC Number: 10653160333180. k. Model Number: ECVC5095B, UPC Number: 10653160333173. l. Model Number: ECVC6075, UPC Number: 10653160338437; Model Number: ECVC6460, UPC Number: 10653160335085. m. Model Number: ECVC2240A, UPC Number: 10653160334361. n. Model Number: ECVC2001, UPC Number: 10653160334415. o. Model Number: ECVC7205A, UPC Number: 10653160342007. p. Model Number: ECVC7200, UPC Number: 10653160341680. q. Model Number: ECVC2205, UPC Number: 10653160332435. r. Model Number: ECVC1970A, UPC Number: 10653160346159. s. Model Number: ECVC5540A, UPC Number: 10653160335009. t. Model Number: ECVC6120, UPC Number: 10653160336532. u. Model Number: ECVC6150, UPC Number: 10653160335054. v. Model Number: ECVC5095B, UPC Number: 10653160333173. w. Model Number: ECVC5585A, UPC Number: 10653160333326; Model Number: ECVC5585B, UPC Number: 10653160357711; Model Number: ECVC8105, UPC Number: 10653160357858. x. Model Number: ECVC7360, UPC Number: 10653160346289. y. Model Number: ECVC3755A, UPC Number: 10653160334804. z. Model Number: ECVC3260, UPC Number: 10653160331704; Model Number: ECVC7860, UPC Number: 10653160351191. aa. Model Number: ECVC2895, UPC Number: 10653160332725. bb. Model Number: ECVC5315, UPC Number: 10653160339465. cc. Model Number: ECVC5310, UPC Number: 10653160336211. dd. Model Number: ECVC1555, UPC Number: 10653160331759. ee. Model Number: ECVC3286, UPC Number: 10653160358398. ff. Model Number: ECVC3285A, UPC Number: 10653160358572. gg. Model Number: ECVC5560A, UPC Number: 10653160336501. hh. Model Number: ECVC6355, UPC Number: 10653160336396. ii. Model Number: ECVC1525, UPC Number: 10653160334545. jj. Model Number: ECVC6850, UPC Number: 10653160338819. kk. Model Number: ECVC5525A, UPC Number: 10653160338130. ll. Model Number: ECVC1300, UPC Number: 10653160331780. mm. Model Number: ECVC885, UPC Number: 10653160333562. nn. Model Number: ECVC105, UPC Number: 10653160331773. oo. Model Number: ECVC5590B, UPC Number: 10653160357728. pp. Model Number: ECVC2235, UPC Number: 10653160334378. qq. Model Number: ECVC6015A, UPC Number: 10653160335146; Model Number: ECVC6015B, UPC Number: 10653160357704. rr. Model Number: ECVC5985A, UPC Number: 10653160333371; Model Number: ECVC5985B, UPC Number: 10653160357797. ss. Model Number: ECVC400, UPC Number: 10653160331827. tt. Model Number: ECVC465, UPC Number: 10653160333074. uu. Model Number: ECVC6070, UPC Number: 10653160335863. vv. Model Number: ECVC5385, UPC Number: 10653160336518; Model Number: ECVC6940, UPC Number: 10653160336709. ww. Model Number: DYNJ44320J, UPC Number: 019532713235. xx. Model Number: DYNJ0429185L, UPC Number: 019532704897. yy. Model Number: DYNJ80297, UPC Number: 019532702177. zz. Model Number: DYNJ61118D, UPC Number: 019532710821. aaa. Model Number: DYNJ41649G, UPC Number: 019532727729. bbb. Model Number: DYNJ58510A, UPC Number: 019348981743. ccc. Model Number: DYNJ42531, UPC Number: 088438992673. ddd. Model Number: PAIN1336, UPC Number: 019348951153. eee. Model Number: DYNJ0198765G, UPC Number: 088994205398. fff. Model Number: DYNJ43060B, UPC Number: 088994276585. ggg. Model Number: DYNJ67149A, UPC Number: 019532717903. hhh. Model Number: ECVC4985, UPC Number: 10653160335269. iii. Model Number: ECVC2940, UPC Number: 10653160335351. jjj. Model Number: DYNJ82079, UPC Number: 019532716736. kkk. Model Number: DYNJ69691, UPC Number: 019348997011. lll. Model Number: DYNJ47645B, UPC Number: 019348995283. mmm. Model Number: DYNJ46545C, UPC Number: 019532725042. nnn. Model Number: DYNJ53481D, UPC Number: 019348981257. ooo. Model Number: DYNJ44334M, UPC Number: 019532713311; Model Number: DYNJ44334N, UPC Number: 019532729949. ppp. Model Number: CDS982998C, UPC Number: 019348927943; Model Number: CDS982998D, UPC Number: 019348992377; Model Number: CDS982998F, UPC Number: 019532712690. qqq. Model Number: DYNJ909393, UPC Number: 019532733558. rrr. Model Number: DYNJ66515A, UPC Number: 019348940616. sss. Model Number: ECVC2320, UPC Number: 10653160332480. ttt. Model Number: ECVC2720, UPC Number: 10653160332657. uuu. Model Number: DYNJ57760C, UPC Number: 019532707939. vvv. Model Number: DYNJ65174D, UPC Number: 019348996215. www. Model Number: DYNJ69298, UPC Number: 019348992541. xxx. Model Number: DYNJ57049G, UPC Number: 019532711039; Model Number: DYNJ57049I, UPC Number: 019532720773. yyy. Model Number: DYNJ81213, UPC Number: 019532709427. zzz. Model Number: SYNJ10303C, UPC Number: 019532711889. aaaa. Model Number: DYNJ60343B, UPC Number: 019532721549; Model Number: DYNJ60343C, UPC Number: 019532728504. bbbb. Model Number: DYNJ50694A, UPC Number: 088994269351. cccc. Model Number: DYNJ40215B, UPC Number: 088827791226. dddd. Model Number: ECVC3705, UPC Number: 10653160332893. eeee. Model Number: ECVC1915, UPC Number: 10653160334446. ffff. Model Number: ECVC1915, UPC Number: 10653160334446. gggg. Model Number: STCVC09US, UPC Number: 10653160342939. hhhh. Model Number: STCVC10US, UPC Number: 10653160343097. iiii. Model Number: ECVC6265, UPC Number: 10653160342922. jjjj. Model Number: DYNJ50712D, UPC Number: 019532726792. kkkk. Model Number: DYNJ64976, UPC Number: 019348923712. llll. Model Number: DYNJ36752B, UPC Number: 019532722602; Model Number: DYNJ41989F, UPC Number: 088994276885; Model Number: DYNJ41989G, UPC Number: 019348931080; Model Number: DYNJ61646A, UPC Number: 019532701431; Model Number: DYNJ62037C, UPC Number: 019348921283; Model Number: DYNJ62037D, UPC Number: 019348989369; Model Number: DYNJ67737, UPC Number: 019348942775; Model Number: DYNJ68538, UPC Number: 019348983311; Model Number: DYNJ68729B, UPC Number: 019532702091. mmmm. Model Number: DYNJ66926, UPC Number: 019348938796; Model Number: DYNJ66926A, UPC Number: 019348988735. nnnn. Model Number: DYNJ0950839C, UPC Number: 088994210129. oooo. Model Number: DYNJ69056, UPC Number: 019348988687; Model Number: DYNJ69056A, UPC Number: 019532706129. pppp. Model Number: DYNJ36738G, UPC Number: 019532705416. qqqq. Model Number: ECVC6555, UPC Number: 10653160336341. rrrr. Model Number: DYNJ35164C, UPC Number: 088994249466. ssss. Model Number: DYNJ0537652AG, UPC Number: 019532701767. tttt. Model Number: DYNJ61373A, UPC Number: 019532701469. uuuu. Model Number: ECVC5855B, UPC Number: 10653160355113. vvvv. Model Number: DYNJ52425K, UPC Number: 019532704235; Model Number: DYNJ52425L, UPC Number: 019532707448; Model Number: DYNJ52425M, UPC Number: 019532717718; Model Number: DYNJ52425N, UPC Number: 019532733932. wwww. Model Number: DYNJ69898, UPC Number: 019348999389. xxxx. Model Number: DYNJ38326D, UPC Number: 019348956435; Model Number: DYNJ38326G, UPC Number: 019532723013. yyyy. Model Number: ECVC2650, UPC Number: 10653160334248. zzzz. Model Number: ECVC7095, UPC Number: 10653160339236.

Label field

Details supplied by the agency

Lot, code or applicability

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ61099B, UPC Number: 019532711185; Model Number: DYNJ61099C, UPC Number: 019532726200. b. Model Number: DYNJ61118C, UPC Number: 019348946397; Model Number: DYNJ61118F, UPC Number: 019532726198. c. Model Number: DYNJ41649G, UPC Number: 019532727729. d. Model Number: ECVC2595, UPC Number: 10653160332596. e. Model Number: CDS984100U, UPC Number: 019532714613; Model Number: CDS984100V, UPC Number: 019532725205. f. Model Number: ECVC2225, UPC Number: 10653160334385. g. Model Number: ECVC7265A, UPC Number: 10653160345145. h. Model Number: ECVC3235, UPC Number: 10653160336112. i. Model Number: ECVC2335, UPC Number: 10653160332497. j. Model Number: ECVC5120B, UPC Number: 10653160333180. k. Model Number: ECVC5095B, UPC Number: 10653160333173. l. Model Number: ECVC6075, UPC Number: 10653160338437; Model Number: ECVC6460, UPC Number: 10653160335085. m. Model Number: ECVC2240A, UPC Number: 10653160334361. n. Model Number: ECVC2001, UPC Number: 10653160334415. o. Model Number: ECVC7205A, UPC Number: 10653160342007. p. Model Number: ECVC7200, UPC Number: 10653160341680. q. Model Number: ECVC2205, UPC Number: 10653160332435. r. Model Number: ECVC1970A, UPC Number: 10653160346159. s. Model Number: ECVC5540A, UPC Number: 10653160335009. t. Model Number: ECVC6120, UPC Number: 10653160336532. u. Model Number: ECVC6150, UPC Number: 10653160335054. v. Model Number: ECVC5095B, UPC Number: 10653160333173. w. Model Number: ECVC5585A, UPC Number: 10653160333326; Model Number: ECVC5585B, UPC Number: 10653160357711; Model Number: ECVC8105, UPC Number: 10653160357858. x. Model Number: ECVC7360, UPC Number: 10653160346289. y. Model Number: ECVC3755A, UPC Number: 10653160334804. z. Model Number: ECVC3260, UPC Number: 10653160331704; Model Number: ECVC7860, UPC Number: 10653160351191. aa. Model Number: ECVC2895, UPC Number: 10653160332725. bb. Model Number: ECVC5315, UPC Number: 10653160339465. cc. Model Number: ECVC5310, UPC Number: 10653160336211. dd. Model Number: ECVC1555, UPC Number: 10653160331759. ee. Model Number: ECVC3286, UPC Number: 10653160358398. ff. Model Number: ECVC3285A, UPC Number: 10653160358572. gg. Model Number: ECVC5560A, UPC Number: 10653160336501. hh. Model Number: ECVC6355, UPC Number: 10653160336396. ii. Model Number: ECVC1525, UPC Number: 10653160334545. jj. Model Number: ECVC6850, UPC Number: 10653160338819. kk. Model Number: ECVC5525A, UPC Number: 10653160338130. ll. Model Number: ECVC1300, UPC Number: 10653160331780. mm. Model Number: ECVC885, UPC Number: 10653160333562. nn. Model Number: ECVC105, UPC Number: 10653160331773. oo. Model Number: ECVC5590B, UPC Number: 10653160357728. pp. Model Number: ECVC2235, UPC Number: 10653160334378. qq. Model Number: ECVC6015A, UPC Number: 10653160335146; Model Number: ECVC6015B, UPC Number: 10653160357704. rr. Model Number: ECVC5985A, UPC Number: 10653160333371; Model Number: ECVC5985B, UPC Number: 10653160357797. ss. Model Number: ECVC400, UPC Number: 10653160331827. tt. Model Number: ECVC465, UPC Number: 10653160333074. uu. Model Number: ECVC6070, UPC Number: 10653160335863. vv. Model Number: ECVC5385, UPC Number: 10653160336518; Model Number: ECVC6940, UPC Number: 10653160336709. ww. Model Number: DYNJ44320J, UPC Number: 019532713235. xx. Model Number: DYNJ0429185L, UPC Number: 019532704897. yy. Model Number: DYNJ80297, UPC Number: 019532702177. zz. Model Number: DYNJ61118D, UPC Number: 019532710821. aaa. Model Number: DYNJ41649G, UPC Number: 019532727729. bbb. Model Number: DYNJ58510A, UPC Number: 019348981743. ccc. Model Number: DYNJ42531, UPC Number: 088438992673. ddd. Model Number: PAIN1336, UPC Number: 019348951153. eee. Model Number: DYNJ0198765G, UPC Number: 088994205398. fff. Model Number: DYNJ43060B, UPC Number: 088994276585. ggg. Model Number: DYNJ67149A, UPC Number: 019532717903. hhh. Model Number: ECVC4985, UPC Number: 10653160335269. iii. Model Number: ECVC2940, UPC Number: 10653160335351. jjj. Model Number: DYNJ82079, UPC Number: 019532716736. kkk. Model Number: DYNJ69691, UPC Number: 019348997011. lll. Model Number: DYNJ47645B, UPC Number: 019348995283. mmm. Model Number: DYNJ46545C, UPC Number: 019532725042. nnn. Model Number: DYNJ53481D, UPC Number: 019348981257. ooo. Model Number: DYNJ44334M, UPC Number: 019532713311; Model Number: DYNJ44334N, UPC Number: 019532729949. ppp. Model Number: CDS982998C, UPC Number: 019348927943; Model Number: CDS982998D, UPC Number: 019348992377; Model Number: CDS982998F, UPC Number: 019532712690. qqq. Model Number: DYNJ909393, UPC Number: 019532733558. rrr. Model Number: DYNJ66515A, UPC Number: 019348940616. sss. Model Number: ECVC2320, UPC Number: 10653160332480. ttt. Model Number: ECVC2720, UPC Number: 10653160332657. uuu. Model Number: DYNJ57760C, UPC Number: 019532707939. vvv. Model Number: DYNJ65174D, UPC Number: 019348996215. www. Model Number: DYNJ69298, UPC Number: 019348992541. xxx. Model Number: DYNJ57049G, UPC Number: 019532711039; Model Number: DYNJ57049I, UPC Number: 019532720773. yyy. Model Number: DYNJ81213, UPC Number: 019532709427. zzz. Model Number: SYNJ10303C, UPC Number: 019532711889. aaaa. Model Number: DYNJ60343B, UPC Number: 019532721549; Model Number: DYNJ60343C, UPC Number: 019532728504. bbbb. Model Number: DYNJ50694A, UPC Number: 088994269351. cccc. Model Number: DYNJ40215B, UPC Number: 088827791226. dddd. Model Number: ECVC3705, UPC Number: 10653160332893. eeee. Model Number: ECVC1915, UPC Number: 10653160334446. ffff. Model Number: ECVC1915, UPC Number: 10653160334446. gggg. Model Number: STCVC09US, UPC Number: 10653160342939. hhhh. Model Number: STCVC10US, UPC Number: 10653160343097. iiii. Model Number: ECVC6265, UPC Number: 10653160342922. jjjj. Model Number: DYNJ50712D, UPC Number: 019532726792. kkkk. Model Number: DYNJ64976, UPC Number: 019348923712. llll. Model Number: DYNJ36752B, UPC Number: 019532722602; Model Number: DYNJ41989F, UPC Number: 088994276885; Model Number: DYNJ41989G, UPC Number: 019348931080; Model Number: DYNJ61646A, UPC Number: 019532701431; Model Number: DYNJ62037C, UPC Number: 019348921283; Model Number: DYNJ62037D, UPC Number: 019348989369; Model Number: DYNJ67737, UPC Number: 019348942775; Model Number: DYNJ68538, UPC Number: 019348983311; Model Number: DYNJ68729B, UPC Number: 019532702091. mmmm. Model Number: DYNJ66926, UPC Number: 019348938796; Model Number: DYNJ66926A, UPC Number: 019348988735. nnnn. Model Number: DYNJ0950839C, UPC Number: 088994210129. oooo. Model Number: DYNJ69056, UPC Number: 019348988687; Model Number: DYNJ69056A, UPC Number: 019532706129. pppp. Model Number: DYNJ36738G, UPC Number: 019532705416. qqqq. Model Number: ECVC6555, UPC Number: 10653160336341. rrrr. Model Number: DYNJ35164C, UPC Number: 088994249466. ssss. Model Number: DYNJ0537652AG, UPC Number: 019532701767. tttt. Model Number: DYNJ61373A, UPC Number: 019532701469. uuuu. Model Number: ECVC5855B, UPC Number: 10653160355113. vvvv. Model Number: DYNJ52425K, UPC Number: 019532704235; Model Number: DYNJ52425L, UPC Number: 019532707448; Model Number: DYNJ52425M, UPC Number: 019532717718; Model Number: DYNJ52425N, UPC Number: 019532733932. wwww. Model Number: DYNJ69898, UPC Number: 019348999389. xxxx. Model Number: DYNJ38326D, UPC Number: 019348956435; Model Number: DYNJ38326G, UPC Number: 019532723013. yyyy. Model Number: ECVC2650, UPC Number: 10653160334248. zzzz. Model Number: ECVC7095, UPC Number: 10653160339236.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 9, 2023
Recall initiation date: May 15, 2023
Center classification date: Aug 3, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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