Z-0573-2015Class II

Arrow Nerve Block Component

Name: Z-0573-2015 Arrow Nerve Block Component
Creator: Arrow International Inc
Published: 2014-11-10
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2014-11-10 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia... on 2014-11-10. FDA classified it as Class II and gives the reason as "Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0573-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-10
Posted: 2014-12-12
Terminated: 2016-09-08
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Nerve Block Component, Product Code: AB-18040-N: 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: Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected].
Quantity in commerce: 786
Distribution: US Nationwide Distribution.
Product codes and lots: Product Number: AB-18040-N; Lot Number: RF2096425, RF2010131, RF1057898, RF0074365, RF0035689

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0573-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0573-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09

Product code CAZ

K121403Class IIContinuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. / cleared 2012-06-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)