FDAClass IIDecember 7, 2022

Aero Blue Performance Surgical Gown recall: Sterility Concern

Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

Why was Aero Blue Performance Surgical Gown recalled?

Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 10680651417340 Lot Number: AH1215T51

Product
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Recalling firm
Owens & Minor Distribution, Inc.
Quantity
72 cases (2160 pouches)
Distribution
IL, IN, WV
Recall date
December 7, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls