Multi-Lumen Central Venous Catheterization Kit
FDA Recall Z-0076-2015 · Posted 2014-10-16
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2014-09-18
Date Terminated2014-12-02
Product Quantity65
Reason for Recall
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.
Firm Action
Arrow International sent an Medical Device Advisory Notifications letter dated September 18, 2014, sent to direct accounts to notify them about the product, problem, and actions to be taken.
Arrow International, Inc. (Arrow) is notifying customers that the label on the outer corrugate for the above mentioned product code and lot number 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.
Arrow International, Inc. is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Labeling False and Misleading
Distribution Pattern
US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.