Recalls / —
—#144761
Product
1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720
- FDA product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected lot / code info
- Catalog Number 381720 - 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer. 3121951 3143801 3190895 3254585 3303872 4051735 4133600 4177944 4219570 4289603 4317642 5063833 5106687 5125665 5230884 5300771 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer 3045792 3106688 3289840 4059581 4203557 5002915 5063827 5125565 5300772
Why it was recalled
The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.
Root cause (FDA determination)
Device Design
Action the firm took
BD isssued an urgent voluntary product recall lettter/recall response card on 3/18/2016.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-18
- Posted by FDA
- 2016-05-18
- Terminated
- 2017-07-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144761. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.