Z-0903-2009

Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number...

Name: Z-0903-2009 Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number...
Creator: Spectranetics Corporation
Published: 2008-10-15
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2008-10-15 / Terminated / root cause: labeling and UDI

FDA source

Spectranetics Corporation began a recall of Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado... on 2008-10-15. The reason FDA records is "Catheter pouch was mislabeled with the wrong size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0903-2009
Status: Terminated
Initiated: 2008-10-15
Posted: 2009-01-30
Terminated: 2009-02-26
Recalling firm: Spectranetics Corp.
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.
Product code: OEX Cardiovascular Catheter Sheath Introducer Kit
Reason for recall: Catheter pouch was mislabeled with the wrong size.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Serial numbers: 080314B02 thru 080314B11, 080314B13 thru 080314B21, and 080314B23 thru 080314B27.

Product code OEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)