Recall Z-0343-2023— Owens & Minor Distribution, Inc.

Name: FDA recall Z-0343-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-31

Class II · Ongoing

Class II FDA medical device recall by Owens & Minor Distribution, Inc., initiated 2022-10-31. It names one FDA 510(k) clearance: K192362. Product: Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734. Reason: Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection.

Recalling firm: Owens & Minor Distribution, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-31
Firm location: Mechanicsville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K192362 — Aero Blue Performance Surgical GownsO&M Halyard, Inc.·cleared 2019-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.