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
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
- Device type
- Heart & Vascular Devices
Timeline
| 9 Oct 2013 | Recall initiated by company | |
| 19 Dec 2013 | Classified by FDA | +71 days |
| 25 Dec 2013 | Published 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.
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