The Recall Desk
SevereFDA (Devices)·Z-1112-2024·Announced 2024-03-06

Medline Medical Kits and Trays Recalled for Potential Sterility Failure

Medline Industries is recalling certain sterile medical kits and trays that contain component solutions with a potential lack of sterility. Non-sterile solutions could result in infection or contamination during medical procedures.

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 is an FDA Class I recall, which requires a minimum severity score of 4 per the established rules. No illnesses or deaths have been reported and the hazard is potential rather than confirmed, so the score does not escalate to Critical.

Plain-English summary

Medline Industries, LP is recalling certain sterile medical kits, trays, and packs that were manufactured using component solutions supplied by Nurse Assist. The affected products include laceration kits and trays, suture trays, UVC insertion trays, bronchoalveolar lavage packs, central line kits, and various infusion and catheter access kits, with approximately 21,154 units affected.

The component solutions affected—specifically 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe—may lack adequate sterility. The potential for non-sterile solutions creates a risk of contamination or infection if these products are used in sterile medical procedures.

These products were distributed nationwide throughout the United States, including Puerto Rico, as well as internationally to Canada, the United Arab Emirates, and Panama. Specific lot numbers for each product type are identified in the FDA recall documentation.

Healthcare facilities and users in possession of affected lots should discontinue use and contact Medline Industries for instructions on replacement or return. The complete list of affected product reference numbers and lot numbers is available from the FDA.

The recalled product

Product
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
Hazard
Affected units
21,154

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)

  • a) REF SUT13935
  • UDI/DI 40193489440714 (case)
  • 10193489440713 (unit)
  • Lot Numbers: 23GBO782
  • 23GBP869
  • 23HBA879
  • 23HBX374
  • b) REF SUT21215
  • UDI/DI 653160325645 (case)
  • 10653160325642 (unit)
  • Lot Numbers: 22EBB078
  • 22FBE772
  • 22GBJ917
  • 22HBN681
  • 22HBW656
  • 22JBB835
  • 23ABL668
  • 23FBT868
  • 23GBK697
  • 23HBU987

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 49 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 49 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · sterility failure

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