Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIAT... — FDA record Z-2321-2023

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. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D; e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747; f. PERIPHERAL PACK, Model Number: DYNJ44960D; g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865; h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B; i. PERMACATH-LF, Model Number: DYNJ42262D; j. PHLEBECTOMY PACK, Model Number: DYNJ47502B; k. PHYSIATRY PACK, Model Number: DYNJ67414; l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A; m. PICC INSERTION PACK, Model Number: DYNJ60038; n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F; o. PICC LINE INSERTION, Model Number: DYNJ39885A; p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B; q. PICC LINE TRAY, Model Number: DYNJ52688A; r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F; s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717; t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990; u. PICC PROCEDURE PACK, Model Number: DYNJ59067; v. PICC TRAY, Model Number: DYNJ49177F; w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; x. PK GEN-RECIPIENT, Model Number: DYNJ41114C; y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A; z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A; aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A; bb. PORT INSERTION PACK, Model Number: CVI4765; cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990; dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C; ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393; ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B; gg. PREP TRAY, Model Number: DYNJRA1498; hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968; ii. PUH AV FISTULA CDS, Model Number: CDS984329J; jj. PURPLE PACK, Model Number: DYNJ62197; kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F; ll. PV PACK, Model Number: DYNJ46549J; mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131; nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B; oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A; pp. RADIOLOGY PACK, Model Number: DYNJ42172A; qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B; rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M; ss. RADIOLOGY TRAY, Model Number: MNS11625; tt. RECIPIENT PACK, Model Number: DYNJ41114B; uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256; vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899; ww. RIGHT HEART TRAY, Model Number: DYNJ40379C; xx. ROBOT, Model Number: DYNJ906112; yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A; zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F; aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J; bbb. RR-SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0785821M, D...
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
233,638 kits
Agency-reported status
Ongoing
Source record identifier
Z-2321-2023

Open the official record

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

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityAll lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ54755B, UPC Number: 088994292536. b. Model Number: DYNJ40306A, UPC Number: 088994260192. c. Model Number: DYNJ0774759P, UPC Number: 019532724613. d. Model Number: DYNJ902261D, UPC Number: 088994275524. e. Model Number: DYNJRA1747, UPC Number: 019348946400. f. Model Number: DYNJ44960D, UPC Number: 019348983324. g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443. h. Model Number: DYNJ904401B, UPC Number: 019348968343. i. Model Number: DYNJ42262D, UPC Number: 088994269795. j. Model Number: DYNJ47502B, UPC Number: 019348964922. k. Model Number: DYNJ67414, UPC Number: 019348996464. l. Model Number: PHS41739A, UPC Number: 088994290680. m. Model Number: DYNJ60038, UPC Number: 088827779327. n. Model Number: CDS982858F, UPC Number: 088827773921. o. Model Number: DYNJ39885A, UPC Number: 088994253993. p. Model Number: DYNJ41873B, UPC Number: 019348956306. q. Model Number: DYNJ52688A, UPC Number: 088994284356. r. Model Number: CDS982859F, UPC Number: 088827773920. s. Model Number: DYNJ47717, UPC Number: 088827751458. t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847. u. Model Number: DYNJ59067, UPC Number: 088994293004. v. Model Number: DYNJ49177F, UPC Number: 088827777434. w. Model Number: DYNDC2399A, UPC Number: 088994244693. x. Model Number: DYNJ41114C, UPC Number: 019532726173. y. Model Number: DYNJ54894A, UPC Number: 019348921355. z. Model Number: DYNJ54894A, UPC Number: 019348921355. aa. Model Number: DYNJ54982A, UPC Number: 019348980895. bb. Model Number: CVI4765, UPC Number: 019348995318. cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261. dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176. ee. Model Number: DYNJ64393, UPC Number: 019348980963. ff. Model Number: DYNJRA1155B, UPC Number: 019348958371; Model Number: DYNJRA1200B, UPC Number: 019348956827. gg. Model Number: DYNJRA1498, UPC Number: 019348979574. hh. Model Number: DYNJ55063A, UPC Number: 019348968054; Model Number: DYNJ57674A, UPC Number: 088827777174; Model Number: DYNJ59795A, UPC Number: 019348956698; Model Number: DYNJ62588, UPC Number: 019348966983; Model Number: DYNJ64372, UPC Number: 019348980722; Model Number: DYNJ64372A, UPC Number: 019348988468; Model Number: DYNJ68968, UPC Number: 019348987039. ii. Model Number: CDS984329J, UPC Number: 088994286535. jj. Model Number: DYNJ62197, UPC Number: 019348963300. kk. Model Number: DYNJ45757F, UPC Number: 088827779258. ll. Model Number: DYNJ46549J, UPC Number: 019348933778. mm. Model Number: DYNJ35574A, UPC Number: 088438953806; Model Number: DYNJ54131, UPC Number: 088994246680. nn. Model Number: DYNJ60698B, UPC Number: 019532706789. oo. Model Number: DYNJ63155A, UPC Number: 019348931402. pp. Model Number: DYNJ42172A, UPC Number: 019348950271. qq. Model Number: DYNJ58225B, UPC Number: 088827777898. rr. Model Number: PHS479840M, UPC Number: 019348968272. ss. Model Number: MNS11625, UPC Number: 065316032213. tt. Model Number: DYNJ41114B, UPC Number: 088994269269. uu. Model Number: DYNJRA1256, UPC Number: 019348951155. vv. Model Number: DYNJ57149, UPC Number: 088994272160; Model Number: DYNJ67899, UPC Number: 019348945449. ww. Model Number: DYNJ40379C, UPC Number: 088994281455. xx. Model Number: DYNJ906112, UPC Number: 019348965663. yy. Model Number: DYNJ60009A, UPC Number: 019348964887. zz. Model Number: DYNJ905826B, UPC Number: 019348978095; Model Number: DYNJ905826C, UPC Number: 019348940758; Model Number: DYNJ905826D, UPC Number: 019532702352; Model Number: DYNJ905826F, UPC Number: 019532721705. aaa. Model Number: DYNJ33546J, UPC Number: 019348956435. bbb. Model Number: DYNJ0785821M, UPC Number: 019348956435; Model Number: DYNJ0785821N, UPC Number: 019348956435; Model Number: DYNJ0785821O, UPC Number: 019532726373. ccc. Model Number: DYNJ62434A, UPC Number: 019348936627. ddd. Model Number: DYNJ0369434M, UPC Number: 019532729542. eee. Model Number: CDS984584L, UPC Number: 088994270130. fff. Model Number: DYNJ53135B, UPC Number: 019348966082; Model Number: DYNJ53135C, UPC Number: 019348946843. ggg. Model Number: DYNJ0416535U, UPC Number: 019348956435; Model Number: DYNJ0416535Y, UPC Number: 019348956435. hhh. Model Number: DYNJ67504A, UPC Number: 019532700961. iii. Model Number: DYNJ57303A, UPC Number: 088827778321; Model Number: DYNJ57303B, UPC Number: 019348936064. jjj. Model Number: DYNJ64027, UPC Number: 019348977993. kkk. Model Number: DYNJ49833J, UPC Number: 019532705946. lll. Model Number: DYNDA2805, UPC Number: 019348984614. mmm. Model Number: DYNJRA0958, UPC Number: 088994261890. nnn. Model Number: DYNJ48153C, UPC Number: 088994276562. ooo. Model Number: DYNJ43777G, UPC Number: 088994291573. ppp. Model Number: DYNJ63339A, UPC Number: 019348929531; Model Number: DYNJ63339B, UPC Number: 019348984061. qqq. Model Number: DYNJ53319C, UPC Number: 019348963449. rrr. Model Number: DYNJ63340, UPC Number: 019348974116. sss. Model Number: DYNJ906391B, UPC Number: 019348981688. ttt. Model Number: DYNDH1190, UPC Number: 088994249424. uuu. Model Number: DYKM2125, UPC Number: 019532704487. vvv. Model Number: DYNJ58424, UPC Number: 088994285183. www. Model Number: DYNJ37099C, UPC Number: 019348956435. xxx. Model Number: DYNJ59062, UPC Number: 088994294165. yyy. Model Number: TVS4300A, UPC Number: 081698202335. zzz. Model Number: TVS4500A, UPC Number: 081698202337; Model Number: TVS4500B, UPC Number: 019532722356. aaaa. Model Number: ULT2175B, UPC Number: 019348958303; Model Number: ULT2175C, UPC Number: 10653160344353. bbbb. Model Number: DYNDV2537, UPC Number: 019532718408. cccc. Model Number: DYNDC2099, UPC Number: 088827729567. dddd. Model Number: DYNJ56535, UPC Number: 088994265334. eeee. Model Number: DYNDH1319, UPC Number: 088994279547. ffff. Model Number: DYNDV2385A, UPC Number: 019532729876. gggg. Model Number: IVS3485A, UPC Number: 065316099015; Model Number: IVS3840A, UPC Number: 019348947673. hhhh. Model Number: DYNDV2038B, UPC Number: 019348991983; Model Number: IVS3300, UPC Number: 065316030766; Model Number: IVS3495A, UPC Number: 065316099305. iiii. Model Number: IVS3820, UPC Number: 065316034231. jjjj. Model Number: DYNDV2371, UPC Number: 019348943086. kkkk. Model Number: DYNJ56507B, UPC Number: 019348944347; Model Number: DYNJ64930, UPC Number: 019348923168. llll. Model Number: DYNDH1112, UPC Number: 10889942277360. mmmm. Model Number: IV8635D, UPC Number: 065316099026. nnnn. Model Number: DYNDV2502, UPC Number: 019532701409. oooo. Model Number: DYNDH1204, UPC Number: 088994251983; Model Number: DYNDH1468A, UPC Number: 019348944003; Model Number: DYNJRA0389, UPC Number: 088438972552; Model Number: DYNDH1204, UPC Number: 10889942519835. pppp. Model Number: DYNJ61433, UPC Number: 019348956517. qqqq. Model Number: DYNJ60006A, UPC Number: 019348981007. rrrr. Model Number: DYNJ51638B, UPC Number: 019348994641; Model Number: DYNJ51638C, UPC Number: 019532703956. ssss. Model Number: DYNDH1492, UPC Number: 019348943446. tttt. Model Number: DYNJ904401B, UPC Number: 019348968343. uuuu. Model Number: DYNJ902259A, UPC Number: 088994225654. vvvv. Model Number: CDS982895I, UPC Number: 088994220768. wwww. Model Number: DYNJ902261D, UPC Number: 088994275524. xxxx. Model Number: DYNJ43593A, UPC Number: 088994225559; Model Number: DYNJ53475D, UPC Number: 019348954775. yyyy. Model Number: VC-PK, UPC Number: 019532717689. zzzz. Model Number: DYNJ63268B, UPC Number: 019348930511; Model Number: DYNJ66079, UPC Number: 019348931744. aaaaa. Model Number: DYNJ61148A, UPC Number: 019348954925. bbbbb. Model Number: DYNJ32397B, UPC Number: 088438991665; Model Number: DYNJ54139A, UPC Number: 088994256499; Model Number: DYNJ59094, UPC Number: 088994293350; Model Number: DYNJ65189C, UPC Number: 019532707200. ccccc. Model Number: DYNJS3005, UPC Number: 088438909956. ddddd. Model Number: DYNJ55841B, UPC Number: 088827775768. eeeee. Model Number: DYNJ64190A, UPC Number: 019348943563. fffff. Model Number: DYNJ0309084D, UPC Number: 088994288526; Model Number: DYNJ38682C, UPC Number: 088994289719; Model Number: DYNJ51248B, UPC Number: 088994287340; Model Number: DYNJ59662A, UPC Number: 019348954814; Model Number: DYNJ59681, UPC Number: 088827777552; Model Number: DYNJ61264, UPC Number: 019348955447. ggggg. Model Number: DYNJ59631, UPC Number: 088827776402. hhhhh. Model Number: DYNDA2076, UPC Number: 088994270850. iiiii. Model Number: DYNJ38264C, UPC Number: 019348956435. jjjjj. Model Number: DYNJ57736A, UPC Number: 088827777970. kkkkk. Model Number: DYNJ59751A, UPC Number: 019348959856. lllll. Model Number: DYNJ20094J, UPC Number: 019348956435; Model Number: DYNJ20094K, UPC Number: 019348956435. mmmmm. Model Number: DYNJ56260B, UPC Number: 019348956982. nnnnn. Model Number: DYNJ64666A, UPC Number: 019348931726. ooooo. Model Number: DYNJ901392D, UPC Number: 019348953951. ppppp. Model Number: DYNJ59246, UPC Number: 088827776729. qqqqq. Model Number: DYNJ53349A, UPC Number: 088994257453. rrrrr. Model Number: DYNJ35988G, UPC Number: 019348956435; Model Number: DYNJ35988I, UPC Number: 019348956435; Model Number: DYNJ35988J, UPC Number: 019532702466. sssss. Model Number: DYNJ56392, UPC Number: 088994264067; Model Number: DYNJ56392A, UPC Number: 019532726140.

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.

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