Bone Marrow Tray kits recalled due to sterility failure
Argon Medical Devices is recalling Bone Marrow Tray kits containing Lidocaine HCL Injection because they do 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: The FDA has classified this as a Class I recall, which per the rubric criteria requires a minimum severity score of 4. Non-sterile injectable medical devices present a serious risk of infection or other adverse health consequences.
Plain-English summary
Argon Medical Devices, Inc. is recalling Bone Marrow Tray kits (REF: CB0033TL; CB0355TLA) containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules. The kits were recalled because they do not meet release criteria for sterility.
The recalled kits were distributed nationwide in the United States, including Puerto Rico, and overseas to Trinidad and Tobago. A total of 680 units are affected.
Patients and healthcare providers in possession of affected kits should stop using them. Consult with healthcare providers regarding appropriate medical follow-up. Affected units may be returned to the manufacturer.
The recalled product
- Product
- Bone Marrow Tray, REF: CB0033TL; CB0355TLA
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 680
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)
- 11652276(3/31/2028)
- CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028)
Distribution
Part of a larger recall action
This product is one of 6 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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