The Recall Desk
SevereFDA (Devices)·Z-2444-2024·Announced 2024-08-14

Medline Procedure Kits Recalled Due to Defective Syringes and Quality Issues

Medline procedure kits containing defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects over 1.6 million units distributed worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I, which indicates a defective medical device with reasonable probability of serious adverse health consequences. The plastic syringes have documented defects (leaks, breakage) in medical procedure kits used in critical procedures. FDA Class I recalls warrant a minimum severity of 4 per the classification rubric.

Plain-English summary

Medline Industries, LP is recalling multiple types of procedure kits that contain plastic syringes affected by quality issues. The affected kits include WMC HYBRID OR PACK, VASCULAR PACK, SALEM CATH LAB-LF, EH PEDIATRIC CATH, ARTERIOGRAM PACK, CATH PACK, PEDS CATH PACK, STEWARD ROCKLEDGE CATH RRS, CATH LAB PACK, and UA/UV CATHETERIZATION TRAY, among others. A total of 1,679,067 units are affected by this recall.

The syringes in these kits have been identified with specific defects including leaks, breakage, and other quality issues. These problems were identified following an FDA Safety Alert issued on March 19, 2024, regarding plastic syringes. The defects may pose a risk to patient health during medical procedures.

The affected procedure kits have been distributed worldwide, including throughout the United States and in multiple international countries. Specific lot numbers have been identified for each product type and are available through the FDA.

Healthcare providers and facilities that have received affected procedure kits should stop using them and contact their Medline representative for replacement products or further instructions. Patients who have concerns about procedures performed with these kits should consult with their healthcare provider.

The recalled product

Product
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ5
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedure Kits
Hazard
Affected units
1,679,067

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • CMPJ08068F
  • Lot Number 24ABN950
  • CMPJ11455B
  • Lot Number 23IBD357
  • DYNJ26938J
  • Lot Number 22FBD709
  • Lot Number 22GBH459
  • Lot Number 22HBR225
  • Lot Number 22IBJ562
  • Lot Number 22JBP469
  • Lot Number 23ABM365
  • Lot Number 23CBM109
  • Lot Number 23DBN340
  • Lot Number 23GBH016
  • Lot Number 23IBS867
  • DYNJ53018
  • Lot Number 21IBX266
  • Lot Number 22GBN555
  • Lot Number 23ABN207
  • DYNJ57729C

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · syringe leak

See all →