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U.S. Department of Health and Human Services

Class 2 Device Recall Customized kits

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 Class 2 Device Recall Customized kitssee related information
Date Initiated by FirmApril 13, 2020
Create DateMay 29, 2020
Recall Status1 Terminated 3 on November 25, 2020
Recall NumberZ-2175-2020
Recall Event ID 85502
Product Classification Expiratory resistance valve, intranasal, for obstructive sleep apnea - Product Code OHP
ProductSterile Custom Packs to be used in surgical procedures.
Code Information ACS Tray Numbers:  AGMV151; Lot # 993201, Exp. Date 01/07/2021 (12 kits) and Lot # 676191,Exp. Date 11/20/2020 (18 kits) WXMV15H; Lot # 663191, Exp. Date 12/03/2020 (32 kits) AGLA66H; Lot # 675191, Exp. Date 11/21/2020 (4 kits) AGLP521; Lot # 648191, Exp. Date 12/18/2020 (6 kits) AGVA31H; Lot # 675191, Exp. Date 11/21/2020 (6 kits) AGIF04F; Lot # 683191, Exp. Date 11/13/2020 (50 kits)    
Recalling Firm/
Manufacturer		 American Contract Systems
Jackson Pointe Commerce
4050 Jacksons Pointe Ct
Zelienople PA 16063-2838
For Additional Information ContactSteve 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
ActionNotification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
Quantity in Commerce2,868 total kits
DistributionUS Nationwide distribution including in the state of Pennsylvania.
Total Product Life CycleTPLC Device Report
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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