FDAJune 12, 2019drug
TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG / 250 ML NS IVPB; TR...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of Assurance of Sterility
What to do
FDA enforcement status: Terminated
Brands named
infusion optionsinfusion
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly2025-05-21
- FDAREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly2025-05-21
- FDAREF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly2025-05-21
- FDAREF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly2025-05-21
- FDAREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly2025-05-21
- FDAREF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly2025-05-21
- FDAREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY2025-05-21
- FDAREF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly2025-05-21
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