Z-1397-2022 Class I Ongoing
FDA device recall Z-1397-2022 was initiated by Bard Access Systems, Inc. on June 20, 2022 and is designated Class I. 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 intraoss… The recall status is ongoing. Affected quantity: 40,734.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- June 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,734
Product Description
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)
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.
Distribution Pattern
Distribution US nationwide and Canada.
Code Information
Catalog/UDI/Lot: D015151NK/801741163586/, 121460, 122145, 123307, 125298, 125534, 125662, 126095, 126467, 126677, 127040, 127711, 128002, 128208, 128778; D015151MK/801741163623/122359; D015251NK/801741163678/121496, 122096, 123306, 125299, 125533, 125535, 126075, 126149, 126178, 126569, 126686, 127118, 127170, 127417, 127756, 128001; 128482, 128829; D015251MK/801741163630/122193; D015351NK/801741163593/125721, 126901, 126939, 128385; D015351MK/801741163647/125842; D015451NK/801741163609/121593, 122169, 123305, 125016, 125517, 125770, 125977, 126299, 126300, 126340, 126575, 127092, 127119, 127300, 127516, 127808, 128120, 128487, 128725; D015451MK/801741163654/122375, 123433; D015551NK/801741163616/125841, 126951, 127003, 127496, 128724; D015551MK/801741163661/125843, 126834; D001001/00801741163579/All Lots