Z-0546-2014Class II

Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set...

Name: Z-0546-2014 Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set...
Creator: Arrow International Inc
Published: 2013-10-09
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2013-10-09 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and... on 2013-10-09. FDA classified it as Class II and gives the reason as "A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin". 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-0546-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-09
Posted: 2013-12-19
Terminated: 2015-09-21
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set 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: A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated October 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of listed affected products/lots you have in stock; return affected products, customer service representative will contact you with RGA# and instructions for the return of the product, and complete enclosed Recall Acknowledgement form and fax to 1-800-343-2935, Attn: Customer Service, even if you have not affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.
Quantity in commerce: 121
Distribution: Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.
Product codes and lots: Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0546-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0546-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19

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)