—#201875

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 Number: CVI3830, CVI4025, CVI4025A; ddd. PICC INSERTION BUNDLE (P/S), Model Number: CVI4025; eee. PICC INSERTION KIT, Model Number: CVI3735, CVI4615; fff. PICC SUPPLEMENTAL KIT, Model Number: DYNDC2373A; ggg. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; hhh. PORT INSERTION KIT, Model Number: MNS11590; iii. PPE BUNDLE KIT, Model Number: DT13351A; jjj. RADIOLOGY TRAY, Model Number: MNS11625; kkk. SCLEROTHERAPY KIT, Model Number: DYNDA2148A; lll. THYROID BIOPSY TRAY-CHOICE, Model Number: DYNDA2446; mmm. THYROID FNA TRAY, Model Number: DYNDA2238, DNDA2238A. nnn. TOTE MCADAMS OSC SHLDR ARTHRO, Model Number: DYKM1790A; ooo. TREATMENT PACK, Model Number: TPO71922-3; ppp. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; qqq

FDA product code: LRP — Tray, Surgical
Device class: Class 1
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: 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.

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 #201875. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.