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Recall Observatory FDA recall evidence

Device 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.

Z-0573-2015

November 10, 2014

Class II

Product summary

Firm
Arrow International Inc
Event
Event 69740
Status
Terminated
Classification
Class II
Quantity
786
Official record key
device-enforcement:Z-0573-2015

Official wording

Reason: Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. 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. No injuries or illnesses have been reported.

Code information: Product Number: AB-18040-N; Lot Number: RF2096425, RF2010131, RF1057898, RF0074365, RF0035689

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. 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. No injuries or illnesses have been reported.