Recall Z-0976-2009
Spectranetics Corporation · initiated July 4, 2008
Product
Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
Codes / lots: Lot Number: 080417D.
Reason for recall
The catheter pouch label was incorrectly labeled with the wrong size.
FDA-determined cause: Error in labeling
Action taken
The mislabeled catheter was returned to Spectranetics. The second possible mislabeled catheter was visually inspected by a Spectranetics representative and confirmed the catheter was labeled correctly.
Details
- Recall number
- Z-0976-2009
- Initiated
- July 4, 2008
- Posted by FDA
- February 11, 2009
- Terminated
- February 13, 2009
- Quantity
- 2 units
- Distribution
- Nationwide Distribution including states of TX and FL.
- Recalling firm
- Spectranetics Corporation, Colorado Springs, CO