Surgical drape packs recalled because open seals may compromise sterility
Orthopedic Pack model 88041-12 and Universal Pack model 77165-06 are recalled because the surgical drape packs may have open seals that could compromise sterility. 1,316 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; compromised sterility on a surgical drape pack is a potential harm and no injuries are reported.
Plain-English summary
The Orthopedic Pack, model 88041-12, UDI-DI 30680651880414, and the Universal Pack, model 77165-06, UDI-DI 30680651771651, are being recalled. Affected lots include AC2424601B expiring 09/02/2029 and AC2424902B expiring 09/05/2029. The recall covers 1,316 units distributed in Georgia, Alabama and Pennsylvania, and in Mexico.
The surgical drape packs may have open seals, which may compromise the sterility of the product. The FDA classified the action as Class II.
Hospitals and surgical centres holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
- Manufacturer
- O&M HALYARD INC
- Affected units
- 1,316
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 (2)
- Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029)
- 77165-06/30680651771651/AC2424902B(09/05/2029)
Distribution
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