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U.S. Department of Health and Human Services

Class 2 Device Recall Spectranetics SLS II 14Fr. Laser Sheath Kit

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  Class 2 Device Recall Spectranetics SLS II 14Fr. Laser Sheath Kit see related information
Date Initiated by Firm October 15, 2008
Date Posted January 30, 2009
Recall Status1 Terminated 3 on February 26, 2009
Recall Number Z-0903-2009
Recall Event ID 50512
Product Classification Laser Sheath Kit - Product Code OEX
Product 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.
Code Information Serial numbers: 080314B02 thru 080314B11, 080314B13 thru 080314B21, and 080314B23 thru 080314B27.
Recalling Firm/
Manufacturer		 Spectranetics Corporation
96 Talamine Ct
Colorado Springs CO 80907
For Additional Information Contact Mike Handley
719-447-2319
Manufacturer Reason
for Recall		 Catheter pouch was mislabeled with the wrong size.
FDA Determined
Cause 2		 Error in labeling
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.
Quantity in Commerce 24 units
Distribution CA, FL, MI, NC, NY, OH, PA, TX, and VA.
Total Product Life Cycle TPLC Device Report
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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