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U.S. Department of Health and Human Services

Class 2 Device Recall Amplatzer Steerable Delivery Sheath

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  Class 2 Device Recall Amplatzer Steerable Delivery Sheath see related information
Date Initiated by Firm November 09, 2021
Create Date April 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0895-2022
Recall Event ID 89714
510(K)Number K212026  
Product Classification Catheter, percutaneous - Product Code DQY
Product Amplatzer Steerable Delivery Sheath
Code Information Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741
Recalling Firm/
Manufacturer		 Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Cynthia Kong
408-845-0883
Manufacturer Reason
for Recall		 Instructions for use were updated.
FDA Determined
Cause 2		 Device Design
Action Impacted consignees will receive a notification letter via registered mail, from an Abbott field representative, or via phone call and a follow-up email where in-person communication is not possible. The product is not being removed from the field and does not need to be returned. The recalling firm is providing additional instructions to reduce the potential for air ingress.
Quantity in Commerce 529 units
Distribution OUS distribution only
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = Abbott Medical
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