Argon Medical Devices Recalls T-LOK Bone Marrow Biopsy Needles
Argon Medical Devices is recalling 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 (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential compromise of sterility.
Plain-English summary
Argon Medical Devices, Inc. is recalling 772 boxes of T-LOK Bone Marrow Biopsy Needles (8G x 4 EXT CAN and 11G x 4 EXT CAN). The recall was initiated after the firm received a customer complaint regarding a potential defect in the forming of the primary package blister. This defect may compromise the sterility of the product inside the tray.
The affected lots are 11157523, 11158179, 11158180, 11159101, and 11159729. The products were distributed nationwide in the United States and internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan. The needles are intended for the purpose of harvesting bone and/or bone marrow specimens.
The U.S. Food and Drug Administration has classified this as a Class II recall. Healthcare providers and facilities should stop using the affected products and contact Argon Medical Devices for instructions on return or replacement.
The recalled product
- Product
- T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 772
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 (5)
- lots: 11157523
- 11158179
- 11158180
- 11159101
- 11159729
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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