Recall archive / FDA device enforcement

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6"... — FDA record Z-2322-2023

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. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ART LINE TRAY, Model Number: ART865; k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560; l. ARTERIAL LINE TRAY, Model Number: ART840; m. ARTHROGRAM TRAY, Model Number: SPEC0232; n. BASIC BIOPSY TRAY, Model Number: DYNDH1534; o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065; p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; q. BIOPSY TRAY, Model Number: DYNDH1661, MNS8705; r. BIOPSY/ASPIRATION TRAY, Model Number: BT235A; s. BRST BX Tray, Model Number: DYNDH1389A; t. CATHETER PREP KIT, Model Number: DYNDC2638, DYNDC2638A; u. CENTRAL LINE INSERTION KIT, Model Number: DT15975; v. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; w. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; x. CONTINUOUS NERVE BLOCK PREP KIT, Model Number: MNS6660; y. CVC ACCESSORY BUNDLE, Model Number: CVI4505; z. CVC INFANT INSERTION PACK, Model Number: CVI4770; aa. CVC INSERTION BUNDLE, Model Number: CVI3940; bb. CVC INSERTION BUNDLE- ADD A CATHETER, Model Number: CVI4905; cc. CVL INSERTION TRAY, Model Number: DYNDC1786A; dd. DIAGNOSTIC PROCEDURE TRAY, Model Number: DYNJRA0585; ee. DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4050; ff. DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number: CVI4655; gg. EXTREMITY PACK, Model Number: CVI4680; hh. FEMORAL ARTERIAL LINE BUNDLE, Model Number: ART1005; ii. FEMORAL ARTERIAL LINE TRAY, Model Number: ART945; jj. FISHLINE KIT, Model Number: CVI4725; kk. FNA TRAY, Model Number: DYNDH1123B; ll. GENERAL ASPIRATION TRAY - CHOICE, Model Number: DYNDH1397; mm. HEMODIALYSIS ACCESS KIT, Model Number: DT12970; nn. IMPLANT ACCESSORY PACK, Model Number: MNS12955; oo. MAX BARRIER ART LINE KIT, Model Number: ART950; pp. MAX BARRIER KIT, Model Number: DYND2673B; qq. MIDLINE INSERTION, Model Number: DYNDC2890; rr. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; ss. MULTI-PURPOSE SPECIALS TRAY, Model Number: MNS8565; tt. MVHS CVC LUMEN TRAY, Model Number: CVI4920; uu. NECK BIOPSY KIT, Model Number: DYNDH1449A; vv. NERVE BLOCK TRAY, Model Number: MNS8315; ww. PARA/THORACENTESIS TRAY, Model Number: DYNDH1292, DYNDH1470, DYNDH1470A, DYNDH1470B; xx. PEDI ULTRASOUND GUIDED PIV KIT, Model Number: IVS3320; yy. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450A; zz. PEDIATRIC ULTRASOUND KIT, Model Number: MNS12995A; aaa. PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; bbb. PERM CATH KIT, Model Number: MNS10755; ccc. PICC INSERTION BUNDLE, Model...
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: 134,514 kits
Agency-reported status: Ongoing
Source record identifier: Z-2322-2023

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: ART960, UPC Number: 10193489190915. b. Model Number: ART970, UPC Number: 10193489190922. c. Model Number: ART1165, UPC Number: 10653160354680. d. Model Number: ART240A, UPC Number: 10653160328025. e. Model Number: ART245A, UPC Number: 10653160328018; Model Number: ART245B, UPC Number: 10653160358442. f. Model Number: ART690, UPC Number: 10653160318019. g. Model Number: ART645, UPC Number: 10653160314394. h. Model Number: MNS8750, UPC Number: 065316027073. i. Model Number: DT22570A, UPC Number: 10653160346074. j. Model Number: ART865, UPC Number: 10653160325062. k. Model Number: ART255, UPC Number: 10653160311997; Model Number: ART560, UPC Number: 10653160310822. l. Model Number: ART840, UPC Number: 10653160322924. m. Model Number: SPEC0232, UPC Number: 10888277507418. n. Model Number: DYNDH1534, UPC Number: 10193489197082. o. Model Number: MNS12065, UPC Number: 10653160331193. p. Model Number: MNS7695A, UPC Number: 10653160343455. q. Model Number: DYNDH1661, UPC Number: 10193489111521; Model Number: MNS8705, UPC Number: 10653160267508. r. Model Number: BT235A, UPC Number: 10653160315919. s. Model Number: DYNDH1389A, UPC Number: 10193489193510. t. Model Number: DYNDC2638, UPC Number: 10889942786428; Model Number: DYNDC2638A, UPC Number: 10193489782813. u. Model Number: DT15975, UPC Number: 065316025244. v. Model Number: DT22260, UPC Number: 10653160329190. w. Model Number: TRICHT1120, UPC Number: 10653160318293. x. Model Number: MNS6660, UPC Number: 00653160223477. y. Model Number: CVI4505, UPC Number: 10653160319047. z. Model Number: CVI4770, UPC Number: 10193489111262. aa. Model Number: CVI3940, UPC Number: 065316027297. bb. Model Number: CVI4905, UPC Number: 10653160355618. cc. Model Number: DYNDC1786A, UPC Number: 10193489199116. dd. Model Number: DYNJRA0585, UPC Number: 10888277580695. ee. Model Number: CVI4050, UPC Number: 10653160278894. ff. Model Number: CVI4655, UPC Number: 10193489190373. gg. Model Number: CVI4680, UPC Number: 10193489198492. hh. Model Number: ART1005, UPC Number: 10193489198232. ii. Model Number: ART945, UPC Number: 10653160330165. jj. Model Number: CVI4725, UPC Number: 10193489199871. kk. Model Number: DYNDH1123B, UPC Number: 10193489193312. ll. Model Number: DYNDH1397, UPC Number: 10888277733206. mm. Model Number: DT12970, UPC Number: 00653160223712. nn. Model Number: MNS12955, UPC Number: 10653160344681. oo. Model Number: ART950, UPC Number: 10653160330226. pp. Model Number: DYND2673B, UPC Number: 10193489191394. qq. Model Number: DYNDC2890, UPC Number: 10193489784213. rr. Model Number: DYNDA2418, UPC Number: 10888277732698. ss. Model Number: MNS8565, UPC Number: 10653160264927. tt. Model Number: CVI4920, UPC Number: 10653160355847. uu. Model Number: DYNDH1449A, UPC Number: 10193489193701. vv. Model Number: MNS8315, UPC Number: 10653160259916. ww. Model Number: DYNDH1292, UPC Number: 10889942742233; Model Number: DYNDH1470, UPC Number: 10193489193787; Model Number: DYNDH1470A, UPC Number: 10193489196818; Model Number: DYNDH1470B, UPC Number: 10193489111248. xx. Model Number: IVS3320, UPC Number: 10653160308300. yy. Model Number: CVI4450A, UPC Number: 10653160320517. zz. Model Number: MNS12995A, UPC Number: 10653160356592. aaa. Model Number: CHT1825, UPC Number: 10653160328988. bbb. Model Number: MNS10755, UPC Number: 10653160314431. ccc. Model Number: CVI3830, UPC Number: 10653160269946; Model Number: CVI4025, UPC Number: 10653160279792; Model Number: CVI4025A, UPC Number: 10193489396058. ddd. Model Number: CVI4025, UPC Number: 10653160279792. eee. Model Number: CVI3735, UPC Number: 10653160261544; Model Number: CVI4615, UPC Number: 10653160327011. fff. Model Number: DYNDC2373A, UPC Number: 10889942492206. ggg. Model Number: DYNDC2399A, UPC Number: 10889942446933. hhh. Model Number: MNS11590, UPC Number: 10653160321293. iii. Model Number: DT13351A, UPC Number: 065316032558. jjj. Model Number: MNS11625, UPC Number: 10653160322139. kkk. Model Number: DYNDA2148A, UPC Number: 10888277734036. lll. Model Number: DYNDA2446, UPC Number: 10888277733121. mmm. Model Number: DYNDA2238, UPC Number: 10888277734173; Model Number: DYNDA2238A, UPC Number: 10193489191554. nnn. Model Number: DYKM1790A, UPC Number: 10193489112412. ooo. Model Number: TPO71922-3, UPC Number: 00860000300636. ppp. Model Number: DYNDH1121C, UPC Number: 10193489193299. qqq. Model Number: MNS2845, UPC Number: 065316006110. rrr. Model Number: IVS3635A, UPC Number: 10193489782011. sss. Model Number: SPEC0291B, UPC Number: 10889942453054. ttt. Model Number: DYNDC2099, UPC Number: 10888277295674. uuu. Model Number: DYNDH1542, UPC Number: 10193489197396. vvv. Model Number: DYNDV2340, UPC Number: 10193489194937. www. Model Number: DYNDV2038A, UPC Number: 10889942784059; Model Number: IVS3505A, UPC Number: 10653160329602; Model Number: MNS9580, UPC Number: 10653160287049; Model Number: IVS3610, UPC Number: 10653160322856. xxx. Model Number: DYNJ0182378A, UPC Number: 10653160328254; Model Number: DYNJ0182378B, UPC Number: 10653160338536. yyy. Model Number: DYNDV2073A, UPC Number: 10889942780198. zzz. Model Number: CVI4430, UPC Number: 10653160314370. aaaa. Model Number: CVI4325, UPC Number: 10653160307037. bbbb. Model Number: DYNDH1492, UPC Number: 10193489193909. cccc. Model Number: DYNDH1652, UPC Number: 10193489111033. dddd. Model Number: DYNDV2536A, UPC Number: 10653160357872. eeee. Model Number: CVI4180, UPC Number: 10653160284451. ffff. Model Number: CVI4265, UPC Number: 10653160291268. gggg. Model Number: DYNDA2076, UPC Number: 10889942708505. hhhh. Model Number: CVI4830A, UPC Number: 10653160353553; Model Number: CVI4830B, UPC Number: 10653160358534. iiii. Model Number: ART685, UPC Number: 10653160314592.

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: ART960, UPC Number: 10193489190915. b. Model Number: ART970, UPC Number: 10193489190922. c. Model Number: ART1165, UPC Number: 10653160354680. d. Model Number: ART240A, UPC Number: 10653160328025. e. Model Number: ART245A, UPC Number: 10653160328018; Model Number: ART245B, UPC Number: 10653160358442. f. Model Number: ART690, UPC Number: 10653160318019. g. Model Number: ART645, UPC Number: 10653160314394. h. Model Number: MNS8750, UPC Number: 065316027073. i. Model Number: DT22570A, UPC Number: 10653160346074. j. Model Number: ART865, UPC Number: 10653160325062. k. Model Number: ART255, UPC Number: 10653160311997; Model Number: ART560, UPC Number: 10653160310822. l. Model Number: ART840, UPC Number: 10653160322924. m. Model Number: SPEC0232, UPC Number: 10888277507418. n. Model Number: DYNDH1534, UPC Number: 10193489197082. o. Model Number: MNS12065, UPC Number: 10653160331193. p. Model Number: MNS7695A, UPC Number: 10653160343455. q. Model Number: DYNDH1661, UPC Number: 10193489111521; Model Number: MNS8705, UPC Number: 10653160267508. r. Model Number: BT235A, UPC Number: 10653160315919. s. Model Number: DYNDH1389A, UPC Number: 10193489193510. t. Model Number: DYNDC2638, UPC Number: 10889942786428; Model Number: DYNDC2638A, UPC Number: 10193489782813. u. Model Number: DT15975, UPC Number: 065316025244. v. Model Number: DT22260, UPC Number: 10653160329190. w. Model Number: TRICHT1120, UPC Number: 10653160318293. x. Model Number: MNS6660, UPC Number: 00653160223477. y. Model Number: CVI4505, UPC Number: 10653160319047. z. Model Number: CVI4770, UPC Number: 10193489111262. aa. Model Number: CVI3940, UPC Number: 065316027297. bb. Model Number: CVI4905, UPC Number: 10653160355618. cc. Model Number: DYNDC1786A, UPC Number: 10193489199116. dd. Model Number: DYNJRA0585, UPC Number: 10888277580695. ee. Model Number: CVI4050, UPC Number: 10653160278894. ff. Model Number: CVI4655, UPC Number: 10193489190373. gg. Model Number: CVI4680, UPC Number: 10193489198492. hh. Model Number: ART1005, UPC Number: 10193489198232. ii. Model Number: ART945, UPC Number: 10653160330165. jj. Model Number: CVI4725, UPC Number: 10193489199871. kk. Model Number: DYNDH1123B, UPC Number: 10193489193312. ll. Model Number: DYNDH1397, UPC Number: 10888277733206. mm. Model Number: DT12970, UPC Number: 00653160223712. nn. Model Number: MNS12955, UPC Number: 10653160344681. oo. Model Number: ART950, UPC Number: 10653160330226. pp. Model Number: DYND2673B, UPC Number: 10193489191394. qq. Model Number: DYNDC2890, UPC Number: 10193489784213. rr. Model Number: DYNDA2418, UPC Number: 10888277732698. ss. Model Number: MNS8565, UPC Number: 10653160264927. tt. Model Number: CVI4920, UPC Number: 10653160355847. uu. Model Number: DYNDH1449A, UPC Number: 10193489193701. vv. Model Number: MNS8315, UPC Number: 10653160259916. ww. Model Number: DYNDH1292, UPC Number: 10889942742233; Model Number: DYNDH1470, UPC Number: 10193489193787; Model Number: DYNDH1470A, UPC Number: 10193489196818; Model Number: DYNDH1470B, UPC Number: 10193489111248. xx. Model Number: IVS3320, UPC Number: 10653160308300. yy. Model Number: CVI4450A, UPC Number: 10653160320517. zz. Model Number: MNS12995A, UPC Number: 10653160356592. aaa. Model Number: CHT1825, UPC Number: 10653160328988. bbb. Model Number: MNS10755, UPC Number: 10653160314431. ccc. Model Number: CVI3830, UPC Number: 10653160269946; Model Number: CVI4025, UPC Number: 10653160279792; Model Number: CVI4025A, UPC Number: 10193489396058. ddd. Model Number: CVI4025, UPC Number: 10653160279792. eee. Model Number: CVI3735, UPC Number: 10653160261544; Model Number: CVI4615, UPC Number: 10653160327011. fff. Model Number: DYNDC2373A, UPC Number: 10889942492206. ggg. Model Number: DYNDC2399A, UPC Number: 10889942446933. hhh. Model Number: MNS11590, UPC Number: 10653160321293. iii. Model Number: DT13351A, UPC Number: 065316032558. jjj. Model Number: MNS11625, UPC Number: 10653160322139. kkk. Model Number: DYNDA2148A, UPC Number: 10888277734036. lll. Model Number: DYNDA2446, UPC Number: 10888277733121. mmm. Model Number: DYNDA2238, UPC Number: 10888277734173; Model Number: DYNDA2238A, UPC Number: 10193489191554. nnn. Model Number: DYKM1790A, UPC Number: 10193489112412. ooo. Model Number: TPO71922-3, UPC Number: 00860000300636. ppp. Model Number: DYNDH1121C, UPC Number: 10193489193299. qqq. Model Number: MNS2845, UPC Number: 065316006110. rrr. Model Number: IVS3635A, UPC Number: 10193489782011. sss. Model Number: SPEC0291B, UPC Number: 10889942453054. ttt. Model Number: DYNDC2099, UPC Number: 10888277295674. uuu. Model Number: DYNDH1542, UPC Number: 10193489197396. vvv. Model Number: DYNDV2340, UPC Number: 10193489194937. www. Model Number: DYNDV2038A, UPC Number: 10889942784059; Model Number: IVS3505A, UPC Number: 10653160329602; Model Number: MNS9580, UPC Number: 10653160287049; Model Number: IVS3610, UPC Number: 10653160322856. xxx. Model Number: DYNJ0182378A, UPC Number: 10653160328254; Model Number: DYNJ0182378B, UPC Number: 10653160338536. yyy. Model Number: DYNDV2073A, UPC Number: 10889942780198. zzz. Model Number: CVI4430, UPC Number: 10653160314370. aaaa. Model Number: CVI4325, UPC Number: 10653160307037. bbbb. Model Number: DYNDH1492, UPC Number: 10193489193909. cccc. Model Number: DYNDH1652, UPC Number: 10193489111033. dddd. Model Number: DYNDV2536A, UPC Number: 10653160357872. eeee. Model Number: CVI4180, UPC Number: 10653160284451. ffff. Model Number: CVI4265, UPC Number: 10653160291268. gggg. Model Number: DYNDA2076, UPC Number: 10889942708505. hhhh. Model Number: CVI4830A, UPC Number: 10653160353553; Model Number: CVI4830B, UPC Number: 10653160358534. iiii. Model Number: ART685, UPC Number: 10653160314592.

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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