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.
FDA Recall Z-0903-2009 · Posted 2009-01-30
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Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeOEX
Date Initiated2008-10-15
Date Terminated2009-02-26
Product Quantity24 units
Reason for Recall
Catheter pouch was mislabeled with the wrong size.
Firm Action
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
Distribution Pattern
CA, FL, MI, NC, NY, OH, PA, TX, and VA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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