—#201866

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, DYNJ0785821N, DYNJ0785821O; ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A; ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M; eee. SMH VASCULAR CDS, Model Number: CDS984584L; fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C; ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y; hhh. SPECIALS PACK, Model Number: DYNJ67504A; iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B; jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027; kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J; lll. STERILE INJECTION PACK, Model Number: DYNDA2805; mmm. SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958; nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C; ooo. SVMMC VASCULAR MAJOR PA

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: All 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.

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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

Timeline

Recall initiated: 2023-05-15
Posted by FDA: 2023-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201866. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.