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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 228
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
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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