Date Initiated by Firm |
April 13, 2020 |
Create Date |
May 29, 2020 |
Recall Status1 |
Terminated 3 on November 25, 2020 |
Recall Number |
Z-2173-2020 |
Recall Event ID |
85502 |
Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
|
Product |
Sterile Custom Packs to be used in surgical procedures. |
Code Information |
ACS Tray Numbers: AGTA481; Lot # 998201, Exp. Date 01/02/2021 (60 kits) WXEN11G; Lot # 994201, Exp. Date 01/06/2021 (32 kits) VSMT20G; Lot # 677191, Exp. Date 11/19/2020 (12 kits) AGHN20J; Lot # 636191, Exp. Date 12/30/2020 (4 kits); Lot # 675191, Exp. Date 11/21/2020 (12 kits) and Lot # 741191, Exp. Date 09/16/2020 (36 kits) AGEN11H; Lot # 657191, Exp. Date 12/09/2020 (66 kits) VSEN11F; Lot # 664191, Exp. Date 12/02/2020 (8 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 |
2868 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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