Class II FDA device recall · Z-2323-2023

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. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810; d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915; e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770; f. IV SECUREMENT KIT, Model Number: DYNDV2407A; g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005; h. MIDLINE INSERTION TRAY, Model Number: CVI4340; i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011; j. MIDLINE KIT 4F SL MB, Model Number: MID0001; k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003; l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A; m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB; n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765; o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B; p. NICU PICC TRAY, Model Number: CVI3740A; q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990; r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B; s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865; t. PICC BUNDLE 5FR DL, Model Number: PICC0013; u. PICC INSERTION BUNDLE, Model Number: DT14560; v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820; w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012; x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; y. PIV BSI KIT, Model Number: BSIPIV1010; z. PIV KIT, Model Number: BSIPIV1004; aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A; bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700; cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A; dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350; ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547; ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006; gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385; hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075; ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011; jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B; kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005; ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715; mm. ULTRASOUND IV START KIT, Model Number: IV8790; nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C; oo. ULTRASOUND PIV KIT, Model Number: IVS3970; pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910; qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125; rr. USG IV START KIT, Model Number: DYNDV2435; ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567; tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01; uu. USGPIV KIT, Model Number: DYNDV2578; vv. USPIV KIT, Model Number: IVS3910; ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880; xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A; yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A; zz. VI PACK, Model Number: DYNJ64871

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: DYNDA2482, UPC Number: 10193489198188.   b. Model Number: ART920, UPC Number: 10653160327899.   c. Model Number: DT19810, UPC Number: 10653160285656.   d. Model Number: CVI4915, UPC Number: 10653160355489.   e. Model Number: IVS3770, UPC Number: 10653160328230.   f. Model Number: DYNDV2407A, UPC Number: 019348981701.   g. Model Number: MID0005, UPC Number: 10653160349181.   h. Model Number: CVI4340, UPC Number: 10653160309475.   i. Model Number: MIDST04011, UPC Number: 10653160350699.   j. Model Number: MID0001, UPC Number: 10193489381627.   k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334.   l. Model Number: PICC0009A, UPC Number: 10193489760231.   m. Model Number: DYNJ80152MB, UPC Number: 10889942733422.   n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515.   o. Model Number: DYNDC2120B, UPC Number: 10193489198270.   p. Model Number: CVI3740A, UPC Number: 10653160324416.   q. Model Number: IVS3990, UPC Number: 10653160345282.   r. Model Number: CVI4450B, UPC Number: 10653160358428.   s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436.   t. Model Number: PICC0013, UPC Number: 10653160351818.   u. Model Number: DT14560, UPC Number: 10653160236887.   v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509.   w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491.   x. Model Number: DYNJ70152MB, UPC Number: 10889942722822.   y. Model Number: BSIPIV1010, UPC Number: 10653160356523.   z. Model Number: BSIPIV1004, UPC Number: 10193489198843.   aa. Model Number: DYNJ68937A, UPC Number: 10193489111545.   bb. Model Number: CVI3700, UPC Number: 10653160259763.   cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391.   dd. Model Number: IVS3350, UPC Number: 10653160313045.   ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246.   ff. Model Number: BSIPIV1006, UPC Number: 10653160356936.   gg. Model Number: DYNDV2385, UPC Number: 10193489195217.   hh. Model Number: IVS4075, UPC Number: 10653160350545.    ii. Model Number: BSIPIV1011, UPC Number: 10653160353317.   jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335.   kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142.   ll. Model Number: IVS3715, UPC Number: 10653160326298.   mm. Model Number: IV8790, UPC Number: 019348936055.   nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858.   oo. Model Number: IVS3970, UPC Number: 10653160343431.   pp. Model Number: CVI3910, UPC Number: 10653160272311.   qq. Model Number: DT16125, UPC Number: 10653160254751.   rr. Model Number: DYNDV2435, UPC Number: 019532704366.   ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455.   tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482.   uu. Model Number: DYNDV2578, UPC Number: 10653160358374.   vv. Model Number: IVS3910, UPC Number: 10653160338871.   ww. Model Number: CVI3880, UPC Number: 10653160272755.   xx. Model Number: STCVC2020A, UPC Number: 10653160350569.   yy. Model Number: STCVC2015A, UPC Number: 10653160350552.   zz. Model Number: DYNJ64871, UPC Number: 019348922536.

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-2323-2023
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-2323-2023 · Source: openFDA enforcement.