—#178849

Product

Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K810675
Affected lot / code info: Lot/Batch Number: PMC 23F19H0224

Why it was recalled

The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Arrow International issued an " Urgent Medical Device Recall Notice" to its US consignee on 12th Dec 2019 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Questions contact your local sales representative or Customer Service at 1-866-396-2111.

Recalling firm

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

Distribution

Distribution pattern: US distribution to SC

Timeline

Recall initiated: 2019-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.