FDAFDA · Food and drugs·Recall number Z-2176-2020
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: AGSBOO6K; Lot # 660191, Exp. Date 12/06/2020 (19 kits) AGDB14J; Lot # 737191, Exp. Date 09/20/2020 (2 kits) AHLA17J; Lot # 653191, Exp. Date 12/13/2020 (12 kits) SVNE16K; Lot # 691191, Exp. Date 11/05/2020 (20 kits) WPLA17I; Lot # 685191, Exp. Date 11/11/2020 (2 kits)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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