—#147271

Product

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K071538
Affected lot / code info: Device Listing # D040746, FDA Product Code FOZ, Product Code: ASK-45854-PUC, ASK-45854-PSFM, ASK-42854-PCSM and ASK-42854-PBW4 Lot # 23F15F1786, 23F15F1862, 23F15G0818, 23F15J0162, 23F15H0460, 23F15F0943, 23F15G0729, 23F15J1084

Why it was recalled

Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.

Root cause (FDA determination)

Process control

Action the firm took

Arrow mailed an Urgent Medical Device Recall Notification letter to customers requesting they immediately discontinue distribution and quarantine any products with the affected lot numbers. A Recall Acknowledgement Form was included with the notification letter for customers to complete and email to recalls @teleflex.com indicating the amount of product on hand.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution: in the states of MA, CA, IL, TN, IL

Timeline

Recall initiated: 2016-06-02
Posted by FDA: 2016-07-06
Terminated: 2017-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.