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U.S. Department of Health and Human Services

Class 2 Device Recall HEMASHIELD Knitted Double Velour Cardiovascular Fabric

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  Class 2 Device Recall HEMASHIELD Knitted Double Velour Cardiovascular Fabric see related information
Date Initiated by Firm January 03, 2018
Date Posted March 20, 2018
Recall Status1 Terminated 3 on July 03, 2018
Recall Number Z-1172-2018
Recall Event ID 79536
510(K)Number K955349  
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
Product HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Code Information UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229
Recalling Firm/
Manufacturer		 GETINGE US SALES LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Josefino Cabinian
973-709-7791
Manufacturer Reason
for Recall		 A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
FDA Determined
Cause 2		 Labeling mix-ups
Action On January 3, 2018 an URGENT MEDICAL DEVICE RECALL NOTICE was issued to the (1) affected customer. A return authorization was issued with the recall letter, which is intended to be returned to the recalling firm. Questions or concerns can be directed to 1-800-528-7486
Quantity in Commerce 1
Distribution FL
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXZ and Original Applicant = MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
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