Recalls / —
—#93316
Product
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
- FDA product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K900263
- Affected lot / code info
- Product # NR-22802-B, Lot # RF0033406
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 #93316. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.