Continuous Peripheral Nerve Block Catheter Kit and Set recallZ-0546-2014 · Arrow International Inc · initiated Oct 9, 2013
Class II Terminated All recalls posted in December 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0546-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 9, 2013
- Posted by the FDA
- Dec 19, 2013
- Recalling firm
- Arrow International Inc
- Quantity
- 121
- Product code
- CAZ
- FDA submissions
- K121403
- 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 description
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.
Code information (models, lots, serial numbers)
Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.
Other devices under the same FDA submission
5 devices cleared under K121403 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN922628Teleflex Incorporated · Anesthesia conduction kit1 recall0 reports
- ARROW IPN923877Teleflex Incorporated · Anesthesia conduction kit1 recall0 reports
- ARROW IPN924957Teleflex Incorporated · Anesthesia conduction kit1 recall0 reports
- ARROW IPN923940Teleflex Incorporated · Anesthesia conduction kit1 report
- ARROW IPN923943Teleflex Incorporated · Anesthesia conduction kit1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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