FDA Enforcement Class II Ongoing

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

Recall: Z-2322-2023 · Reported August 9, 2023

Enforcement

Recall Number: Z-2322-2023
Event ID: 92399
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: August 9, 2023
Initiation Date: May 15, 2023
Classification Date: August 3, 2023
Address: 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

Description

Reason

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

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.

Distribution

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

Quantity

134,514 kits