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U.S. Department of Health and Human Services

Class 3 Device Recall Turbo Elite 0.9mm Turbo Elite RX

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  Class 3 Device Recall Turbo Elite 0.9mm Turbo Elite RX see related information
Date Initiated by Firm July 04, 2008
Date Posted February 11, 2009
Recall Status1 Terminated 3 on February 13, 2009
Recall Number Z-0976-2009
Recall Event ID 50548
510(K)Number K071227  
Product Classification Catheter, peripheral, atherectomy - Product Code MJQ
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.
Code Information Lot Number: 080417D.
Recalling Firm/
Manufacturer		 Spectranetics Corporation
96 Talamine Ct
Colorado Springs CO 80907
For Additional Information Contact Mike Handley
719-447-2319
Manufacturer Reason
for Recall		 The catheter pouch label was incorrectly labeled with the wrong size.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 2 units
Distribution Nationwide Distribution including states of TX and FL.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MJQ and Original Applicant = SPECTRANETICS CORP.
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