Class II FDA device recall · Z-2322-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2322-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2322-2023 · Source: openFDA enforcement.