—#101243

Product

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 product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K030937
Affected lot / code info: Lot # MF0126544

Why it was recalled

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.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Nationwide Distribution including the state of North Carolina.

Timeline

Recall initiated: 2011-06-17
Posted by FDA: 2011-07-29
Terminated: 2012-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.