| Class 2 Device Recall SLS II Laser sheath kit. | |
Date Initiated by Firm | March 16, 2009 |
Date Posted | June 01, 2009 |
Recall Status1 |
Terminated 3 on November 28, 2011 |
Recall Number | Z-1264-2009 |
Recall Event ID |
51438 |
PMA Number | P960042 |
Product Classification |
laser catheter sheath - Product Code OEX
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Product | Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer. |
Code Information |
Lot number CJJ09B18A |
Recalling Firm/ Manufacturer |
Spectranetics Corporation 9965 Federal Dr Colorado Springs CO 80921-3617
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For Additional Information Contact | 719-447-2318 |
Manufacturer Reason for Recall | Catheter outer jacket may split during use. |
FDA Determined Cause 2 | Process control |
Action | Spectranetics notified the 8 recipients of the catheters by letter on 3/17/2009. They were told that a Spectranetics sales rep would contact them to coordinate the return of the suspect devices. Questions were referred to 719-447-2462 or 719-447-2539. |
Quantity in Commerce | 17 units |
Distribution | Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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