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Recall Observatory FDA recall evidence

Device product

Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

Z-1965-2013

July 31, 2013

Class II

Product summary

Firm
Arrow International Inc
Event
Event 65829
Status
Terminated
Classification
Class II
Quantity
156
Official record key
device-enforcement:Z-1965-2013

Official wording

Reason: Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.

Code information: Catalog # AK-17702-CDC, lot # RF2083258

Distribution pattern: AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.