—#131025

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.

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: 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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

BD sent an 'Urgent:Voluntary Product Recall Letters/Notice of Return ' dated October 9, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, quarantine the affected product, and return all affected product with the completed Notice of Return form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue a credit. Customers who do not have of the affected product were also asked to complete the Notice of Return form indicating (0) quantity and return form back to BD by fax to 1-201-847-6990. If the product was further distributed customers were instructed to identify their customers and notify them at once of the product recall. Customers with questions were instructed to call 201-847-4267.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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

Timeline

Recall initiated: 2014-10-09
Posted by FDA: 2014-12-12
Terminated: 2015-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.