Multi-Lumen Central Venous Catheterization Kit

FDA device recall Z-0076-2015 · posted 2014-10-16 · Terminated

Recall details

Recalling firm

Arrow International Inc

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.

Action taken

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

Status

Terminated

Product code

DQY

Quantity affected

65

Distribution

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

Date initiated

2014-09-18

Date posted

2014-10-16

Date terminated

2014-12-02

Location

Reading, PA

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