510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1690-2016Class II

1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog...

Becton Dickinson & Co / initiated 2016-03-18 / Terminated / root cause: design

Becton Dickinson & Company began a recall of 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"... on . FDA classified it as Class II and gives the reason as "The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1690-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
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
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall
The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.
Root cause tag
design
FDA root cause
Device Design
Action
BD isssued an urgent voluntary product recall lettter/recall response card on 3/18/2016.
Quantity in commerce
1,305,150 units
Distribution
Nationwide
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1690-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1690-2016Class IITerminatedVoluntary: Firm initiated