Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colo
FDA device recall Z-0698-2008 · posted 2008-02-05 · Terminated
Recall details
- Recalling firm
- Spectranetics Corporation
- 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.
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 64
- Distribution
- Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.
- Date initiated
- 2007-12-10
- Date posted
- 2008-02-05
- Date terminated
- 2008-02-08
- Location
- Colorado Springs, CO
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