FDA Recall Open, Classified

Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga, D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga, D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga, D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga, D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga, D015551MK/ BD Manual Driver Needle Kit 55mm x 15G, D001001/ BD Intraosseous Powered Driver (drill)

Recall: Z-1397-2022 · Initiated June 20, 2022

Recall

Recall Number: Z-1397-2022
Event Number: 90315
Firm: Bard Access Systems, Inc.
FEI Number: 3006260740
Product Code: FMI
Status: Open, Classified
Root Cause: Process change control
Initiated: June 20, 2022
Posted: July 22, 2022
Address: 605 N 5600 W, Salt Lake City, UT, 84116-3738

Description

Reason

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

Action

On 06/20/22 BD mailed or emailed recall notices to customers asking them to: 1)Quarantine all affected devices. Destroy needle kits and keep intraosseous drivers quarantined until they can be inspected and repaired, if required, by firm sales representatives. 2) Share this notice with all users within your facility and network and with any organization where the potentially affected products have been transferred. 3) There is no replacement product at this time. The firm will notify customers when replacement products are available. 4) If you purchased affected product from a distributor, contact this distributor for further instructions. 5) If you purchased products directly, complete and return the response form. 6) Distributors were asked to identify all customers within their distribution network that purchased any affected product and to provide a copy of the customer letter. Recall Notice: https://bdx.force.com/CC360/s/impactedproducts?language=en_US&id=7018a000001Gn1tAAC Customers requiring further assistance can contact the North American Regional Complaint Center 1-844-823-5433, say "Recall" when prompted, Mon-Fri 8:00AM-5:00PM CT or [email protected]

Distribution

Distribution US nationwide and Canada.

Quantity

40,734