Medline wound irrigation kits recalled for potential sterility defects
Medline Industries is recalling approximately 2,205 wound irrigation kits due to potential lack of sterility in component solutions. Non-sterile irrigation solutions pose a risk of infection during wound care.
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 medical device recall. Although no illnesses or injuries have been reported, FDA Class I recalls are assigned only for conditions with serious potential for harm. The potential for non-sterile solutions in wound care applications creates significant risk of infection and is classified as Severe (4) in the absence of reported incidents.
Plain-English summary
Medline Industries, LP is recalling certain wound irrigation kits (model CHP WOUND IRRIGATION KIT, REF DYK1017614W) that were manufactured using components supplied by Nurse Assist. The recalled kits contain 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes that may not meet sterility requirements.
The components used in these kits could be non-sterile, which poses a risk of contamination when used for wound irrigation. Non-sterile solutions can introduce infection at the wound site during patient care.
A total of 2,205 units have been distributed nationwide in the United States, including Puerto Rico, as well as to Canada, the United Arab Emirates, and Panama. The affected lot numbers are 22CBE151, 22FBR897, 22HBA156, and 23ABA354, with unit UDI/DI 10884389599402 and case UDI/DI 40884389599403.
Healthcare facilities and individuals who have these kits should discontinue use immediately. Affected users should consult with healthcare providers regarding any wound care procedures that may have used these products, particularly if signs of infection develop.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,205
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 (6)
- UDI/DI 40884389599403 (case)
- 10884389599402 (unit)
- Lot Numbers: 22CBE151
- 22FBR897
- 22HBA156
- 23ABA354
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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