Reported Aug 3, 2022 · Ongoing

Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/…

Bard Access Systems, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bard Access Systems, Inc. · 605 N 5600 W · Salt Lake City, UT · 84116-3738

Is this the product you have?

  • Intraosseous needle and driver
  • Catalog/Device NameD015151NK/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)
Lot codes and dates

12 of 12 products

Products covered by this recall
#BarcodesProduct as published
1801741163586Catalog/UDI/Lot: D015151NK/801741163586/, 121460, 122145, 123307, 125298, 125534, 125662, 126095, 126467, 126677, 127040, 127711, 128002, 128208, 128778
2801741163623D015151MK/801741163623/122359
3801741163678D015251NK/801741163678/121496, 122096, 123306, 125299, 125533, 125535, 126075, 126149, 126178, 126569, 126686, 127118, 127170, 127417, 127756, 128001
4128482, 128829
5801741163630D015251MK/801741163630/122193
6801741163593D015351NK/801741163593/125721, 126901, 126939, 128385
7801741163647D015351MK/801741163647/125842
8801741163609D015451NK/801741163609/121593, 122169, 123305, 125016, 125517, 125770, 125977, 126299, 126300, 126340, 126575, 127092, 127119, 127300, 127516, 127808, 128120, 128487, 128725
9801741163654D015451MK/801741163654/122375, 123433
10801741163616D015551NK/801741163616/125841, 126951, 127003, 127496, 128724
11801741163661D015551MK/801741163661/125843, 126834
1200801741163579D001001/00801741163579/All Lots
Amount recalled
40,734

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 2:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.