The Recall Desk
HighFDA (Devices)·Z-2247-2021·Announced 2021-08-18

Jamshidi Bone Marrow Biopsy Needles Recalled for Packaging Seal Defects

Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi bone marrow biopsy needles due to incomplete or open packaging seals that may compromise sterility. No illnesses or injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving sterile instruments with potential sterility compromise due to packaging defects. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' scoring as High (3). No reported illnesses or injuries are documented.

Plain-English summary

Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi Bone Marrow Biopsy/Aspiration Needles, including models TJM6008, TJC3513, TJM4011, TJC4011, TJM4008, and TJC4008. Approximately 3,961 devices have been distributed in the United States and internationally.

The recall was initiated due to complaints of incomplete or open packaging seals on certain units. These packaging defects could allow non-sterile conditions, compromising the safety of the devices for invasive procedures such as bone marrow biopsy and aspiration.

The devices were distributed nationwide in the United States and in international markets including Australia, Belgium, China, Japan, Mexico, Singapore, Taiwan, and other regions. The affected products are identified by their specific catalog numbers and UDI codes documented with the FDA.

Patients and healthcare providers should discontinue use of affected units and contact Bard Peripheral Vascular Inc. for device replacement or further instructions. As of this recall announcement, no illnesses or injuries have been reported in association with this packaging defect.

The recalled product

Product
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Bone Marrow Biopsy / Aspiration Needle
Hazard
Affected units
3,961

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 (11)

  • Catalog Number//UDI: TJM6008/(01)10885403044595(17)241031(10)0001330707
  • TJC3513/(01)1088540344014(17)241031(10)0001330400
  • TJM4011/(01)10885403044588(17)241031(10)0001330949
  • TJC4011/(01)10885403044052(17)241031(10)0001331232
  • TJM4008/(01)10885403044564(10)0001331230(17)241031
  • TJC4008/(01)10885403044038(17)241130(10)0001334951
  • Serial Numbers: 0001330707
  • 0001330400
  • 0001331232
  • 0001331230
  • 0001334951

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Bard Peripheral Vascular 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 3 products in this recall →

Related recalls

Same manufacturer · Bard Peripheral Vascular Inc

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Same hazard · sterility loss

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