Medline Surgical Convenience Kits Recalled for Sterility Compromise
Medline Industries is recalling 981 surgical convenience kits nationwide because the perforated outer bag does not maintain sterile conditions. Only the kit contents remain sterile, not the exterior wrapping.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with a sterility defect. The perforated bag prevents the outside wrapping from maintaining sterile conditions, creating a contamination risk. No illnesses or injuries have been reported.
Plain-English summary
Medline Industries, LP is recalling 981 surgical convenience kits distributed nationwide. The recall affects two product types: the MEDLINE PERF. ASSOC. CUT DOWN TRAY (Reorder Number BM17BAD) and the MEDLINE ARM/MINOR DRAPE CSTM (Reorder Number DYNJCD0063).
The recall is due to a defect in the perforated bag used in these kits. The perforated bag does not allow the outside wrapping of the kit to maintain sterile conditions. As a result, only the contents inside the kit wrapping are sterile, while the outside wrapping is not.
The specific affected lots are Lot #22HMG957 (Cut Down Tray kits) and Lot #22HMG490 (Arm/Minor Drape kits). Healthcare facilities and providers with these kits should identify affected units using the provided lot numbers and reorder numbers.
The recalled product
- Product
- Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- sterility-failure
- 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 (6)
- a) Reorder number DYNDC2733
- GTIN 40888277783974
- Lot # 22HMG957
- b) Reorder number SUT14640
- GTIN 40653160184158
- Lot # 22HMG490
Distribution
Distributed nationwide across the United States.
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