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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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
- 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.
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