| Class 2 Device Recall Customized kits |  |
Date Initiated by Firm | April 13, 2020 |
Create Date | May 29, 2020 |
Recall Status1 |
Terminated 3 on November 25, 2020 |
Recall Number | Z-2177-2020 |
Recall Event ID |
85502 |
Product Classification |
Orthopedic tray - Product Code OJH
|
Product | Sterile Custom Packs to be used in surgical procedures. |
Code Information |
ACS Tray Numbers: WXCT12E; Lot # 998201, Exp. Date 001/02/2021 (70 kits) PTHS10C; Lot # 664191, Exp. Date 12/02/2020 (2 kits) AVHA64H; Lot # 663191, Exp. Date 12/06/2020 (30 kits) WXPO16G; Lot # 639191, Exp. Date 12/27/2020 (26 kits) and Lot # 689191, Exp. Date 11/07/2020 (6 kits) VSSA12G; Lot # 646191, Exp. Date 12/20/2020 (12 kits) AGBA20H: Lot 3 970191, Exp. Date 01/30/20 (2 kits) WXSA12H; Lot # 653191, Exp. Date 12/13/2020 (40 kits) WXKA26H; Lot # 981201, Exp. Date 01/19/2021 (18 kits) and Lot # 639191, Exp. Date 12/27/2020 (32 kits) WXHA64H; Lot # 682191, Exp. Date 11/14/2020 (18 kits); Lot # 636191, Exp. Date 12/30/2020 (121 kits) and Lot # 684191, Exp. Date 11/12/2020 (6 kits) AGKA26H; Lot # 992201, Exp. Date 01/08/2021 (64 kits) |
Recalling Firm/ Manufacturer |
American Contract Systems Jackson Pointe Commerce 4050 Jacksons Pointe Ct Zelienople PA 16063-2838
|
For Additional Information Contact | Steve Theissen 952-926-3515 |
Manufacturer Reason for Recall | The surgical gowns were manufactured in a facility that is not registered by the FDA. |
FDA Determined Cause 2 | Process control |
Action | Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal. |
Quantity in Commerce | 2,8,68 total kits |
Distribution | US Nationwide distribution including in the state of Pennsylvania. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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