Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Recalled by MEDLINE INDUSTRIES, LP - Northfield Due to Potential for the labeled sterile ultrasound gel component...

Date: May 15, 2023
Company: MEDLINE INDUSTRIES, LP - Northfield
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MEDLINE INDUSTRIES, LP - Northfield directly.

Affected Products

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

Quantity: 218,163 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MEDLINE INDUSTRIES, LP - Northfield

MEDLINE INDUSTRIES, LP - Northfield has 822 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report