FDAFDA · Food and drugs·Recall number Z-0572-2015
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
Published December 17, 2014 · Recall initiated: October 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
BD Insyte Autoguard may have potential damage along the body of the catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Company
- Distributor
- Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.
- Lot
- Distributed in USA REF#381433 20 G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65ml/min Lot numbers 4139786, Exp May-17; 4161662, Jun-17; 4164960, Jun-17; 4167812, Jun-17; 4174713, Jun-17; 4182668, Jun-17; 4182668, Jul-17 REF 381434 20 G x 1.16 in. BD Insyte Autoguard 1.1 x 30 mm 60 ml/min Lot numbers 4105724, Apr-17; 4107722, Apr-17; 4113707, Apr-17; 4113713, Apr-17 Distributed outside of USA REF# 381833 20G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65 ml/min Lot4143917, May -17 REF 3811834 20 G x 1.16 in. BD Insyte AUtoguard 1.1 x 30 mm 60ml/min Lot numbers 4119700, May-17; 4119730, May-17; 4129576, May-17; 4147742, May-17; 4107722, Apr-17
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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