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Terminated

Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

FDA Recall Z-2894-2011 · Posted 2011-07-29

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeCAZ
Date Initiated2011-06-17
Date Terminated2012-10-01
Product Quantity95 kits

Reason for Recall

Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.

Firm Action

Arrow International, Inc. sent an "Urgent Medical Device Recall" letter dated June 17, 2011 to all affected customers. The letter describes the problem and provides recommendations including; quarantine affected product, return of product, and send an acknowledgement form back to manufacturer. For additional information call 800 233-3187.

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution including the state of North Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030937STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PKArrow International, Inc. · 2003-04-23

Official Source

View FDA Recall →

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

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