Recall Z-1370-2011
St. Jude Medical Cardiovascular Division · initiated January 26, 2011
Product
MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.
Codes / lots: Model - Batch #: A0030/1 - 32730001; 32765005; 33253005; 347830070 A0031/1 - 32730003; 32765007; 347830080; 33253006 A0032/1 - 32730002; 32765006; 34783090; 32985001 A0033/1 - 32765008; 33253007; 347830100
Reason for recall
St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may
FDA-determined cause: Process control
Action taken
The firm, St. Jude Medical, sent an "Urgent Medical Device Recall Notice" dated January 26, 201,1 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue use of the product (MitraXs Self Adjusting Atrial Retractor batches) and remove from inventory. St. Jude began production of a new batch of units that will bear the labeling of St. Jude Medical. Shipment of these units started on January 10, 2011. Note: A St. Jude Medical Sales Representative will contact the customer to facilitate removal and reconciliation of the affected product. If you have any questions or concerns, please contact your St. Jude Medical Sales Representative or 651-490-4470 and/or 612-310-7936.
Details
- Recall number
- Z-1370-2011
- Initiated
- January 26, 2011
- Posted by FDA
- February 17, 2011
- Terminated
- May 31, 2012
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 450
- Distribution
- Worldwide distribution: USA including states of: NJ, OH, MI, and MN; and countries including: BELGIUM, FRANCE, GERMANY, SWITZERLAND, and UNITED KINGDOM.
- Recalling firm
- St. Jude Medical Cardiovascular Division, Minnetonka, MN