—#130176

Product

Multi-Lumen Central Venous Catheterization Kit

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K862056
Affected lot / code info: Catolog No - AK-12703 lot number RF3039028

Why it was recalled

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.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

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

Timeline

Recall initiated: 2014-09-18
Posted by FDA: 2014-10-16
Terminated: 2014-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130176. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.