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Recall Observatory FDA recall evidence

Device product

Multi-Lumen Central Venous Catheterization Kit

Z-0076-2015

September 18, 2014

Class II

Product summary

Firm
Arrow International Inc
Event
Event 69290
Status
Terminated
Classification
Class II
Quantity
65
Official record key
device-enforcement:Z-0076-2015

Official wording

Reason: Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.

Code information: Catolog No - AK-12703 lot number RF3039028

Distribution pattern: US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.