BD Intraosseous Needle Kits recalled for mechanical failure and safety defects
BD Intraosseous Needle Kits have been recalled due to mechanical failures that could prevent emergency vascular access. Affected units nationwide and in Canada may experience stylet removal problems, safety mechanism failures, or driver malfunction.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. The device failures—potential needle assembly removal, safety mechanism failure, and driver malfunction—could prevent emergency vascular access during critical medical situations. No deaths or hospitalizations are reported in the source text.
Plain-English summary
The FDA has issued a Class I recall of BD Intraosseous Needle Kits manufactured by Bard Access Systems, Inc. The devices, distributed across the United States and Canada, may exhibit three types of failures: excessive force required to remove the stylet may cause removal of the entire needle assembly and loss of vascular access; the stylet safety mechanism may fail to engage during removal; and metal discs in the powered driver may stick, rendering it unusable.
Intraosseous needles provide emergency vascular access when conventional IV lines cannot be placed. These devices are critical for delivering fluids and medications during emergency medical situations. Malfunction could delay or prevent necessary emergency care.
Approximately 40,734 units of various catalog numbers and lot numbers have been distributed. The recall affects both manual and powered driver kits in multiple needle sizes.
Healthcare facilities and individuals with affected products should contact Bard Access Systems, Inc. for return or replacement instructions and verify their inventory against the specific lot numbers listed in the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 40,734
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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