Surgical Drape Packs With Open Seals May Compromise Sterility
O&M Halyard is recalling 1,316 surgical drape packs (Models 88041-12 and 77165-06) with open seals that may compromise product sterility. Products were distributed nationwide in Georgia, Alabama, Pennsylvania, and Mexico.
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: This is a risk-of-harm product (surgical drape packs used in sterile procedures) with a theoretical hazard (open seals may compromise sterility) and no reported illnesses or injuries. Per the rubric, products with theoretical hazards and no reported injury are at most score 3.
Plain-English summary
O&M Halyard Inc. is recalling 1,316 Orthopedic Pack (Model 88041-12) and Universal Pack (Model 77165-06) surgical drape packs. These products may have open seals, which could compromise the sterility of the product.
These surgical drape packs are designed for sterile field applications where seal integrity is critical to maintaining product sterility. Open seals pose a potential risk by allowing the introduction of contaminants to the sterile product.
The affected products were distributed nationwide in Georgia, Alabama, Pennsylvania, and Mexico. The recall includes Orthopedic Packs (Model 88041-12, UDI-DI 30680651880414, Lot AC2424601B expiring 09/02/2029) and Universal Packs (Model 77165-06, UDI-DI 30680651771651, Lot AC2424902B expiring 09/05/2029).
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
- Hazard
- open-seals
- sterility-compromise
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
Distributed nationwide across the United States.
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