—#147757

Product

Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K810675
Affected lot / code info: Lot/Batch Numbers: 23F14M0829, 23F14M0986

Why it was recalled

Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: US distribution in the states of TN and KY.

Timeline

Recall initiated: 2016-06-02
Posted by FDA: 2016-07-12
Terminated: 2017-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147757. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.