—#133695

Product

ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle

FDA product code: DSP — System, Balloon, Intra-Aortic And Control
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K021462
Affected lot / code info: Lot Number: 18F14M0001

Why it was recalled

Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Arrow International notified Users, Distributors, Risk Managers by letter dated February 5, 2015. The letter explains the labeling error and requests immediately discontinue use and quarantine product. Customers were instructed to complete the Recall Acknowledgement Form and return by fax to 1-855-419-8507 whether they have or do not have the affected product. Customers with questions were instructed to contact their local sales representataive or Customers Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Belgium

Timeline

Recall initiated: 2015-02-05
Posted by FDA: 2015-03-02
Terminated: 2016-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133695. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.