Surgical Gown Recall Due to Potential Open Seal Pouches Affecting Sterility
Owens & Minor Distribution recalls Aero Blue Performance Surgical Gowns due to potential open seal pouches that could compromise sterility and result in non-sterile products being used in surgery.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential that non-sterile products could lead to patient infection. Per the severity rubric, this qualifies as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Owens & Minor Distribution, Inc. is recalling Aero Blue Performance Surgical Gowns, XL (Code: 41734) due to potential open seal pouches. This packaging defect could compromise sterility and result in non-sterile surgical gowns being used during procedures, creating a risk of patient infection.
The affected products are lot number AH1215T51, distributed in Illinois, Indiana, and West Virginia. The recall involves 72 cases containing 2,160 pouches total.
Healthcare facilities that received affected batches should verify the integrity of pouches before use. Any pouches with visible seal compromise should not be used. Facilities should contact their supplier or Owens & Minor Distribution for guidance on verification or replacement of affected products.
The recalled product
- Product
- Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
- Manufacturer
- Owens & Minor Distribution, Inc.
- Category
- Medical Device
- Hazard
- open-seal
- sterility-compromise
- infection-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 (1)
- UDI-DI: 10680651417340 Lot Number: AH1215T51
Distribution
Distributed in 3 states:
- IL
- IN
- WV
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