General Biopsy Tray with Lidocaine HCL Injection subject to sterility recall
Argon Medical Devices is recalling General Biopsy Tray kits containing Lidocaine HCL Injection because the kits 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 classified this as Class I. Per the rubric, FDA Class I recalls are never scored below 4. Sterility failure in an injectable medical device presents a significant risk of infection and adverse health consequences.
Plain-English summary
Argon Medical Devices, Inc. is recalling General Biopsy Tray kits (REF: GUTS1000) that contain Lidocaine HCL Injection USP 1% 10mg/mL in 5mL ampules. The kits do not meet the required release criteria for sterility.
The recalled product was distributed nationwide in the United States, including Puerto Rico, as well as to Trinidad and Tobago. The affected product quantity is 1,800 units with the code GUTS1000/20886333001594:00886333001590 and lot expiration date of 3/31/2028.
Patients and healthcare providers who have received this product should not use it. Contact Argon Medical Devices, Inc. for instructions on returns or proper disposal. Consult with your healthcare provider if you have questions about your medical care related to this product.
The recalled product
- Product
- General Biospy Tray, REF: GUTS1000
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
- sterility-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
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