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Terminated

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.

FDA Recall Z-0976-2009 · Posted 2009-02-11

Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeMJQ
Date Initiated2008-07-04
Date Terminated2009-02-13
Product Quantity2 units

Reason for Recall

The catheter pouch label was incorrectly labeled with the wrong size.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution including states of TX and FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071227CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15Spectranetics Corp. · 2007-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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