The Recall Desk
ModerateFDA (Devices)·Z-1422-2018·Announced 2018-04-25

Carefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns

Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices because the integrity of the sterile packaging is potentially compromised.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential compromise in sterile packaging integrity without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices. The affected products include sterile needles in 15G x 100mm, 16G x 100mm, 17G x 100mm, and 16G x 70mm configurations. The recall is being conducted because the integrity of the sterile packaging is potentially compromised.

The affected products were distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, the Netherlands, New Zealand, the Philippines, Singapore, South Africa, Taiwan, Thailand, the United Arab Emirates, and Vietnam. Specific product codes and lot numbers are SN1015X (Lot 0000840334), SN1016X (Lot 0000848028), SN1017X (Lot 0000848018), and SN7016X (Lot 0000848017).

Healthcare providers and consumers should stop using the affected Jamshidi Needle Biopsy devices and contact Carefusion 2200 Inc for further instructions or a return.

The recalled product

Product
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
790

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 (4)

  • Product Code: SN1015X / LOT 0000840334
  • Product Code: SN1016X / LOT 0000848028
  • Product Code: SN1017X / LOT 0000848018
  • Product Code SN7016X / LOT 0000848017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Carefusion 2200 Inc

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Same hazard · sterility compromise

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