T-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Class I recalls are defined as situations where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. Failure to meet sterility criteria for a medical device intended for injection presents a risk of serious infection.
Plain-English summary
Argon Medical Devices, Inc. is recalling T-Lok Bone Marrow Tray kits (REF: BMT1104STL, BMET1104TL, BMT1104CATL) that contain Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules. The recall was initiated because the kits failed to meet release criteria for sterility.
The affected kits were distributed nationwide in the United States, including Puerto Rico, and internationally to Trinidad and Tobago. A total of 850 units are involved in this recall.
Customers who have received these kits should stop using them immediately and contact Argon Medical Devices for instructions on return or replacement.
The recalled product
- Product
- T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
- sterility-failure
- infection-risk
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 (2)
- BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028)
- BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026)
Distribution
Distributed nationwide across the United States.
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