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U.S. Department of Health and Human Services

Class 2 Device Recall Banner Health Systems Cysto Pack

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 Class 2 Device Recall Banner Health Systems Cysto Packsee related information
Date Initiated by FirmJanuary 31, 2025
Date PostedMarch 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1424-2025
Recall Event ID 96321
Product Classification Endoscope introducer kit - Product Code NWU
ProductBrand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Code Information Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
7300 W Detroit St
Chandler AZ 85226-2410
For Additional Information ContactMarlene Jones
602-799-5321
Manufacturer Reason
for Recall		Sterility assurance with procedure trays
FDA Determined
Cause 2		Process change control
ActionOn 1/31/25 customers were notified via. phone about the recall. On February 11, 2025, Owens & Minor, the parent company of American Contract System issued a "Urgent: Medical Device Recall" notification via email to affected customers. 1. DISCONTINUE USE of the procedure trays listed in Table 1 above. 2. RETURN PRODUCT: Contact your ACS Sales Representative for instructions on returning all product to ACS. 3. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this recall and all unused product is returned, and maintain records of effectiveness. 4. Complete the attached Recall Response Form and return as soon as possible.
Quantity in Commerce800
DistributionUS: AZ OUS: None
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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