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
- sterility-failure
- infection-risk
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.
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