—#171719

Product

Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K153487
Affected lot / code info: Lot/Batch Number: 23F18B0581 GTIN:20801902120704

Why it was recalled

Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC

Root cause (FDA determination)

Employee error

Action the firm took

Arrow International initiated recall notification letter on 13th December 2018 via FedEx 2-day mail describing problem ,health risk and action to take:, immediately discontinue use and quarantine the products. 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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2018-12-13
Terminated: 2020-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171719. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.