Spectranetics Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Spectranetics Corporation
Lot Codes / Batch Numbers
Serial numbers: 080314B02 thru 080314B11, 080314B13 thru 080314B21, and 080314B23 thru 080314B27.
Products Sold
Serial numbers: 080314B02 thru 080314B11, 080314B13 thru 080314B21, and 080314B23 thru 080314B27.
Spectranetics Corporation is recalling Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot num due to Catheter pouch was mislabeled with the wrong size.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Catheter pouch was mislabeled with the wrong size.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, MI, NY, NC, OH, PA, TX, VA
Page updated: Jan 10, 2026