Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Summary
The FDA issued a Class II for Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 by Owens & Minor Distribution, Inc.. Reason: Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection.
Details
Source
Device Recall
External ID
Z-0343-2023
Action Date
2022-12-07
Status
Ongoing
Category
device
Product Description
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Lot/Code Info: UDI-DI: 10680651417340 Lot Number: AH1215T51
Quantity Affected: 72 cases (2160 pouches)
Reason for Recall
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Distribution
IL, IN, WV
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-31
Company
Mechanicsville, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Owens & Minor Distribution, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Owens & Minor Distribution, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Owens & Minor Distribution, Inc. have FDA actions?
Owens & Minor Distribution, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0343-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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