The Recall Desk
HighFDA (Devices)·Z-2189-2015·Announced 2015-07-29

Argon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles

Argon Medical Devices is recalling specific T-Lok bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.

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: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Argon Medical Devices, Inc. is recalling specific lots of T-Lok Bone Marrow Biopsy Needles (8G x 4 Ext Can, 11G x 4 Ext Can, and 13G x 4) in the United States. The recall involves 10,290 units distributed across the country.

The recall is being issued because of a potential defect in the forming of the primary package of the blister. This defect may compromise the sterility of the product inside the tray. The affected lot numbers are 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, and 11099173.

Healthcare facilities and consumers should check their inventory for these specific part numbers and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
10,290

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 (18)

  • Lot Numbers: 11088295
  • 11088596
  • 11088597
  • 11089105
  • 11089366
  • 11094182
  • 11094681
  • 11094912
  • 11095381
  • 11095844
  • 11095845
  • 11095951
  • 11096558
  • 11097278
  • 11097504
  • 11098024
  • 11098647
  • 11099173

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Argon Medical Devices, 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 2 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

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Same hazard · sterility compromise

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