Medline Instrument Trays Recalled for Potential Sterility Defect
Medline Industries is recalling 228 medical device trays due to potential sterility defects in component solutions used in 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 medical device recall. Although no illnesses or injuries have been reported, the FDA classification indicates a serious potential for adverse health consequences from non-sterile medical device components. FDA Class I recalls warrant a minimum severity score of 4.
Plain-English summary
Medline Industries, LP is recalling 228 units of medical device trays and kits labeled as DYNDL1550. These were manufactured using specific lots of Nurse Assist components including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes.
The recall was issued due to a potential lack of sterility in the component lots, which could result in the solutions being non-sterile. The affected lot numbers are 22HBT075, 22IBF551, 23HBA140, and 23IBO702.
The affected products were distributed in the United States (including Puerto Rico), Canada, the United Arab Emirates, and Panama. If you have these kits, contact Medline Industries for recall guidance and instructions.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-defect
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 40884389740690 (case)
- 10884389740699 (unit)
- Lot Numbers: 22HBT075
- 22IBF551
- 23HBA140
- 23IBO702
Distribution
Distributed nationwide across the United States.
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