Medline wound care trays recalled due to sterility defect
Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This product is classified as FDA Class I, which is a criterion for Critical severity per the rubric. FDA Class I recalls represent the agency's most serious classification level.
Plain-English summary
Medline Industries, LP is recalling Wound Care Trays (latex-free, REF DYND06002) manufactured using certain lots of Nurse Assist sterile components, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall affects 72,624 units.
The recall was initiated due to the potential lack of sterility in the solution components, which could result in non-sterile solutions. The affected products were distributed nationwide in the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Wound care tray
- Hazard
- lack-of-sterility
- contamination-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)
- REF DYND06002
- UDI/DI 40080196816645 (case)
- 10080196816644 (unit)
- Lot Numbers: 2022041290
- 2022051090
- 2022062090
- 2022081190
- 2022081790
- 2022101990
- 2022102090
- 2022111490
- 2023050390
- 2023050890
- 2023042890
- 2023050490
- 2023063090
- 2023062990
- 2023070390
- 2023072890
- 2023082590
Distribution
Distributed nationwide across the United States.
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