BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accid

FDA device recall Z-0572-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FOZ

Quantity affected

US- 296,800 devices; OUS - 3,250,150 devices

Distribution

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

Date initiated

2014-10-09

Date posted

2014-12-12

Date terminated

2015-04-24

Location

Franklin Lakes, NJ