CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report

Continuous Peripheral Nerve Block Catheter Kit recalled

Arrow International is recalling Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block, distributed nationwide in the US. The recall was initiated on 9 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.
Quantity recalled121

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0546-2014
FDA event ID
66589
Recalling firm
Arrow International, Reading, PA
Classification
Class II
Status
Terminated
Recall initiated
9 Oct 2013
FDA classified
19 Dec 2013
Reported
25 Dec 2013
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

9 Oct 2013Recall initiated by company
19 Dec 2013Classified by FDA+71 days
25 Dec 2013Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide AlabamaCaliforniaColoradoConnecticutGeorgiaIdahoKansasLouisianaMassachusettsMissouriMississippiNew JerseyNew YorkPennsylvaniaPuerto RicoTexasWisconsin

Questions about this recall

Is Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block recalled?

Yes. Arrow International recalled Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block on 9 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0546-2014.

Why was it recalled?

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.

Which lots are affected?

Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Arrow International

All 525

Other Heart & Vascular Devices recalls

All 6,199