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Terminated

AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.

FDA Recall Z-0591-2008 · Posted 2008-01-23

Recalling FirmAngioScore Inc.
Recall StatusTerminated
Product CodeNWX
Date Initiated2007-11-13
Date Terminated2008-03-25
Product Quantity40 units

Reason for Recall

Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton

Firm Action

The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.

Root Cause

Process control

Distribution Pattern

Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.

Official Source

View FDA Recall →

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

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