Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectra
FDA device recall Z-0903-2009 · posted 2009-01-30 · Terminated
Recall details
- Recalling firm
- Spectranetics Corporation
- Reason for recall
- Catheter pouch was mislabeled with the wrong size.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- OEX
- Quantity affected
- 24 units
- Distribution
- CA, FL, MI, NC, NY, OH, PA, TX, and VA.
- Date initiated
- 2008-10-15
- Date posted
- 2009-01-30
- Date terminated
- 2009-02-26
- Location
- Colorado Springs, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.