Z-0698-2008

Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by...

Name: Z-0698-2008 Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by...
Creator: Spectranetics Corporation
Published: 2007-12-10
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2007-12-10 / Terminated / root cause: packaging

FDA source

Spectranetics Corporation began a recall of Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907 on 2007-12-10. The reason FDA records is "Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0698-2008
Status: Terminated
Initiated: 2007-12-10
Posted: 2008-02-05
Terminated: 2008-02-08
Recalling firm: Spectranetics Corp.
Product: Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
Product code: DQY Catheter, Percutaneous
Reason for recall: Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.
Quantity in commerce: 64
Distribution: Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.
Product codes and lots: Lot Number: 0709158

Product code DQY

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)