—#93313

Product

Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K993691
Affected lot / code info: Product # CDC-45802-B1A, Lot # RF9127302

Why it was recalled

Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.

Recalling firm

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

Distribution

Distribution pattern: The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.

Timeline

Recall initiated: 2010-07-29
Posted by FDA: 2010-09-25
Terminated: 2012-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.