Recall Z-1397-2022 ยท FMI Needle, Hypodermic, Single Lumen
Bard Access Systems, Inc.
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 Ne
| Date | Jul 22, 2022 (initiated Jun 20, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| 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, co |
| Quantity | 40,734 |
| Distribution | Distribution US nationwide and Canada. |
| FDA record | Open on fda.gov |