Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
- Company
- Spectranetics Corporation
- Recall Initiated
- October 15, 2008
- Posted
- January 30, 2009
- Terminated
- February 26, 2009
- Recall Number
- Z-0903-2009
- Quantity
- 24 units
- Firm Location
- Colorado Springs, CO
Reason for Recall
Catheter pouch was mislabeled with the wrong size.
Distribution
CA, FL, MI, NC, NY, OH, PA, TX, and VA.
Lot / Code Info
Serial numbers: 080314B02 thru 080314B11, 080314B13 thru 080314B21, and 080314B23 thru 080314B27.
Root Cause
Error in labeling
Action Taken
Consignees were notified by sales representatives who visually inspected their inventory. The sales representatives were given a form to fill out to confirm whether the consignee had the catheters with the serial number still in inventory. The forms were faxed back to Spectranetics indicating if the catheters were used or not and if they were not used, were they labeled correctly. For assistance, contact Spectranetics Corporation at 1-719-447-2319.
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