Data Foundry

Medical device recalls 2013

Continuous Peripheral Nerve Block Catheter Kit and Set Continuous… — Class II medical device recall Z-0546-2014

Terminated recall by Arrow International Inc, reported 2013-12-25, distributed nationwide. A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable

Recall numberZ-0546-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArrow International Inc, Reading, PA, United States
Recall initiated2013-10-09
Classified2013-12-19
Reported by FDA2013-12-25
Terminated2015-09-21
DistributedNationwide (US)
Countries outside the USSG
Quantity121
Reason classeslabeling
Lot numbersRF0059570, RF0088984, RF0128588, RF1071764, RF2069779, RF2108983, RF3052266

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0546-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.