FDAFDA · Food and drugs·Recall number Z-2175-2020
Sterile Custom Packs to be used in surgical procedures.
Published June 10, 2020 · Recall initiated: April 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The surgical gowns were manufactured in a facility that is not registered by the FDA.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- American Contract Systems
- Distributor
- US Nationwide distribution including in the state of Pennsylvania.
- Lot
- ACS Tray Numbers: AGMV151; Lot # 993201, Exp. Date 01/07/2021 (12 kits) and Lot # 676191,Exp. Date 11/20/2020 (18 kits) WXMV15H; Lot # 663191, Exp. Date 12/03/2020 (32 kits) AGLA66H; Lot # 675191, Exp. Date 11/21/2020 (4 kits) AGLP521; Lot # 648191, Exp. Date 12/18/2020 (6 kits) AGVA31H; Lot # 675191, Exp. Date 11/21/2020 (6 kits) AGIF04F; Lot # 683191, Exp. Date 11/13/2020 (50 kits)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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