The Recall Desk
ModerateFDA (Devices)·Z-0546-2014·Announced 2013-12-25

Arrow International Recalls Nerve Block Catheter Kits Due to Labeling Error

Arrow International is recalling 121 Continuous Peripheral Nerve Block Catheter Kits because the packaging incorrectly describes the stimulator cable connector.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a labeling inconsistency. Per the rubric, minor labeling errors and low-risk issues without reported injuries or illnesses fall under the Moderate severity level.

Plain-English summary

Arrow International Inc. is recalling 121 units of the Continuous Peripheral Nerve Block Catheter Kit and Set. The recall was initiated after a labeling inconsistency was discovered in the product packaging.

The lidstock of the kit states that it contains a stimulator cable with a 1.5mm socket. However, the kits actually contain a stimulator cable with a 1.5mm pin. This discrepancy between the label and the physical product constitutes the reason for the recall.

The affected products are identified by product number AB-07200 Stimulator Adapter Cable and specific lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, and RF1071764. These kits were distributed worldwide, including nationwide in the United States and in Singapore. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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.
Affected units
121

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

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

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically: