Z-2170-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 13, 2020
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,868 kits
Product Description
Sterile Custom Packs to be used in surgical procedures.
Reason for Recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Distribution Pattern
US Nationwide distribution including in the state of Pennsylvania.
Code Information
ACS Tray Numbers: WPPP52E; Lot # 723191, Exp. Date 10/04/2020 (24 kits) AGMM60M; Lot # 656191, Exp. Date 12/10/2020 (20 kits) VSMI14G; Lot # 643191, Exp. Date 12/23/2020 (60) and Lot #71891, Exp. Date 10/09/2020 (6 kits) WXOLO48H; Lot # 654191, Exp. Date 12/12/2020 (6 kits) AGKD5OJ; Lot # 997201, Exp. Date 01/03/2021 (26 kits) AGME44J; Lot # 997201, Exp. Date 01/03/2021 (24 kits) AGMA31K; Lot # 642191, Exp. Date 12/24/2020 (96 kits) AGMI141; Lot # 671191, Exp. Date 11/25/2020 (36 kits) and Lot # 789191, Exp. Date 07/30/2020 (14 kits) AVMA31I; Lot # 675191, Exp. Date 11/21/2020 (2 kits) AVMI14H; Lot # 639191, Exp. Date 12/27/2020 (70 kits) WXMI14H; Lot # 650191, Exp. Date 12/16/2020 (160 kits) AGLO48H; Lot # 670191, Exp. Date 11/26/2020 (30 kits) SVMA21I; Lot # 654191, Exp. Date 12/12/2020 (30 kits)