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Terminated

American Catheter / Cholangiogram Catheter 9100 Series.

FDA Recall Z-2191-2015 · Posted 2015-07-22

Recalling FirmAmerican Catheter Corp
Recall StatusTerminated
Product CodeGBZ
Date Initiated2015-03-17
Date Terminated2016-12-14
Product Quantity890 devices.

Reason for Recall

Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.

Firm Action

Consignees were contacted by telephone of the affected lot number and sent a Recall Script dated 3/17/2015 giving instructions how to respond to this recall.

Root Cause

Process control

Distribution Pattern

Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.

Official Source

View FDA Recall →

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

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