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Recall Observatory FDA recall evidence

Device product

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.

Z-0572-2015

October 09, 2014

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 69604
Status
Terminated
Classification
Class II
Quantity
US- 296,800 devices; OUS - 3,250,150 devices
Official record key
device-enforcement:Z-0572-2015

Official wording

Reason: BD Insyte Autoguard may have potential damage along the body of the catheter.

Code information: 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

Distribution pattern: Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD Insyte Autoguard may have potential damage along the body of the catheter.