The Recall Desk
ModerateFDA (Devices)·Z-0573-2015·Announced 2014-12-17

Arrow Recalls Nerve Block Components Due to Labeling Inconsistency

Arrow International Inc is recalling specific lots of Continuous Nerve Block Components because the packaging incorrectly identifies the needle gauge. No injuries or illnesses have been reported.

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 and involves a minor labeling error where the physical product is correct but the packaging is mislabeled. No injuries or illnesses have been reported, fitting the criteria for moderate severity.

Plain-English summary

Arrow International Inc is recalling 786 units of the Continuous Nerve Block Component, Product Code AB-18040-N. The recall is due to a labeling inconsistency where the product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size.

The affected lots are RF2096425, RF2010131, RF1057898, RF0074365, and RF0035689. These products were distributed nationwide in the United States. The device permits the placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

No injuries or illnesses have been reported in connection with this recall. The agency has classified this as a Class II recall.

The recalled product

Product
Arrow Nerve Block Component, Product Code: AB-18040-N: 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
786

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 (6)

  • Product Number: AB-18040-N
  • Lot Number: RF2096425
  • RF2010131
  • RF1057898
  • RF0074365
  • RF0035689

Distribution

Distributed nationwide across the United States.