Medline Laceration Trays Recalled Due to Sterility Defect
Medline is recalling laceration trays and medical kits with approximately 12,000 units due to sterility defects in component solutions. Non-sterile medical devices could pose infection risk during wound care 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: FDA Class I classification requires a minimum severity score of 4 per the rubric. Sterility defects in medical devices for direct patient wound care represent serious safety risks.
Plain-English summary
Medline Industries, LP is recalling certain laceration trays and medical kits due to a sterility defect in manufacturing. The recalled products include ER Laceration Tray (REF SUT12825), Laceration Tray (REF SUT21580), and Laceration Tray (REF DYNDL1484B), affecting approximately 12,000 units.
The kits were manufactured with specific lots of Nurse Assist brand solutions—0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe—that may not meet required sterility standards. Sterile medical supplies that are non-sterile pose a risk of infection when used in wound care and laceration procedures.
The affected products were distributed nationwide across the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Healthcare facilities and medical professionals who have these kits should immediately discontinue use and contact Medline or their medical supply provider for replacement stock.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 12,000
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 SUT12825
- UDI/DI 00653160356199 (case)
- 10653160356196 (unit)
- Lot Numbers: 23CBX773
- 23EBB756
- 23HBC776
- b) REF SUT21580
- UDI/DI 40653160991077 (case)
- 10653160991076 (unit)
- Lot Numbers: 22EBC554
- 22EBK107
- 22EBR701
- 22GBW369
- 22JBI962
- 22KBA966
- 23DBD424
- 23FBK832
- 23GBR277
- 23HBX352
- c) REF DYNDL1484B
Distribution
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.
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