Z-2894-2011

Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of...

Name: Z-2894-2011 Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of...
Creator: Arrow International Inc
Published: 2011-06-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2011-06-17 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for... on 2011-06-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2894-2011
Status: Terminated
Initiated: 2011-06-17
Posted: 2011-07-29
Terminated: 2012-10-01
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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.
Product code: CAZ Anesthesia Conduction Kit
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.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 95 kits
Distribution: Nationwide Distribution including the state of North Carolina.
Product codes and lots: Lot # MF0126544

Product code CAZ

K030937Class IIStimucath Continuous Nerve Block Set, Models Ab-02030, Ab-02060, Ab-02090, Ab-02030-Pk, Ab-02060-Pk, Ab-02090-PkArrow International, Inc. / cleared 2003-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)