Date Initiated by Firm |
April 13, 2020 |
Create Date |
May 29, 2020 |
Recall Status1 |
Terminated 3 on November 25, 2020 |
Recall Number |
Z-2172-2020 |
Recall Event ID |
85502 |
Product Classification |
Cardiac catheterization kit - Product Code OES
|
Product |
Sterile Custom Packs to be used in surgical procedures. |
Code Information |
ACS Tray Numbers: AGD1401; Lot # 647191, Exp. Date 06/31/2020 (72 kits) and Lot # 685191 Exp. Date 03/31/2020 (6 kits) WPP147H; Lot # 684191, Exp. Date 11/12/2020 (20 kits) and Lot # 723191 Exp. Date 10/04/2020 (4 kits) SVOH38N; Lot # 654191, Exp. Date 12/12/2020 (32 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 kits total |
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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