Home / Recalls / Owens & Minor Distribution, Inc. / Z-0343-2023

Z-0343-2023 Class II Ongoing

Recalled by Owens & Minor Distribution, Inc. — Mechanicsville, VA

FDA device recall Z-0343-2023 was initiated by Owens & Minor Distribution, Inc. on October 31, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 72 cases (2160 pouches).

Recall Details

Product Type
Devices
Report Date
December 7, 2022
Initiation Date
October 31, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72 cases (2160 pouches)

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

Distribution Pattern

IL, IN, WV

Code Information

UDI-DI: 10680651417340 Lot Number: AH1215T51

Other recalls by Owens & Minor Distribution, Inc.

  • Z-1059-2023 Class III — FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, (January 3, 2023)
  • Z-0888-2017 Class II — Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 (October 31, 2016)
  • Z-0735-2016 Class II — MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-s (November 17, 2015)
  • Z-0733-2016 Class II — MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-s (November 17, 2015)
  • Z-0734-2016 Class II — MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-s (November 17, 2015)
  • Z-0416-2015 Class II — MediChoice Dual-Release Folding Walker with 5" wheel (June 25, 2014)
  • Z-1192-2013 Class II — MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, (March 26, 2013)

FDA data resources