—#126455

Product

Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.

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: lot #23F14A0375

Why it was recalled

Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification "

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca

Timeline

Recall initiated: 2014-03-24
Posted by FDA: 2014-04-24
Terminated: 2015-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126455. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.