—#161626

Product

ARROW PICC powered by ARROW VPS Stylet

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K121941
Affected lot / code info: CDC 34041 VPS Lot# 23F17A0037 23F17B0035

Why it was recalled

The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990.

Recalling firm

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

Distribution

Distribution pattern: AZ, CA, GA, MA, MO, NY, VA

Timeline

Recall initiated: 2017-10-17
Terminated: 2020-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161626. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.