Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/
FDA device recall Z-1397-2022 · posted 2022-07-22 · Open, Classified
Recall details
- Recalling firm
- Bard Access Systems, Inc.
- Reason for recall
- 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 taken
- 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 productcomplaints@bd.com
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- FMI
- Quantity affected
- 40,734
- Distribution
- Distribution US nationwide and Canada.
- Date initiated
- 2022-06-20
- Date posted
- 2022-07-22
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD Intraosseous Infusion System (K203193) | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | 2021-03-04 |
| Piper GO-IO Intraosseous Infusion System (K191976) | Piper Access, LLC | 2019-11-13 |