Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
This recall has been terminated (originally issued February 5, 2008).
- Company
- Spectranetics Corporation
- Recall Initiated
- December 10, 2007
- Posted
- February 5, 2008
- Terminated
- February 8, 2008
- Recall Number
- Z-0698-2008
- Quantity
- 64
- Firm Location
- Colorado Springs, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.
Lot / Code Info
Lot Number: 0709158
Root Cause
Packaging process control
Action Taken
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.
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