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U.S. Department of Health and Human Services

Class 2 Device Recall Aligned Medical T and A Pack

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 Class 2 Device Recall Aligned Medical T and A Packsee related information
Date Initiated by FirmAugust 16, 2024
Date PostedOctober 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0030-2025
Recall Event ID 95306
Product Classification General surgery tray - Product Code LRO
ProductAligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Code Information Catalog Number: AMS11482 UDI-DI code: B098AMS114820 Lot Numbers: 205275
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information ContactJeff Jensen
406-373-7438
Manufacturer Reason
for Recall		Due to convenience kits containing a kit component that is under a recall action for improper use.
FDA Determined
Cause 2		Use error
ActionOn 08/16/2024, the firm email an "URGENT: MEDICAL DEVICE PRODUCT CORRECTION" Letter to customers informing them that Cardinal Health is conducting a product correction for its Salem Sump PVC Tubes. These Sump PVC tubes were included in the Aligned Medical convenience kits. The correction for this Recall is an updated product label, an electronic instruction for use (eIFU). The updated labeling is to address improper use of the Sump PVC tubes which can lead to breakage of the Salem Sump Anti Reflux Valve (ARV) that increases risk to patients. Customers are instructed to: 1. Review your inventory for the affected kits, all lots are impacted 2. Communicate the change to the use instructions with all personnel that utilize Salem Sump" products contained within AMS kits. 3. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product correction. Your notification to your customers should include a copy of this notification letter. 4. Please complete and return the AMS Urgent Medical Device Product Correction Response Required form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. For questions or concerns, contact Aligned Medical Solutions at fieldcorrectiveaction@alignedmedicalsolutions.com
Quantity in Commerce40 packs
DistributionU.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
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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