General Angio Pack Sterilization Assurance Cannot Be Confirmed
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
What this means for you
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: This FDA Class II medical device recall involves unconfirmed sterilization assurance on critical angiography equipment. While no illnesses or injuries have been reported, the risk of contamination and functionality loss in these devices constitutes a high-risk product where harm has not yet been reported. Per the severity rubric, this qualifies as High (Score 3) rather than Severe because it is Class II without reported hospitalizations or injuries.
Plain-English summary
American Contract Systems Inc is recalling 956 General Angio Pack kits (Model Nos LLAP75G, LLAP75G-01, LLAP75G-02, LLAP75G-03) because the manufacturer could not confirm that sterilization assurance requirements were met during production.
Without confirmed sterilization, these angiography packs may lose functionality or become contaminated. A medical device used in angiography procedures that lacks verified sterilization poses an infection risk and could delay or prolong patient treatment.
The affected kits were distributed nationwide. The lot numbers involved in this recall are 70-050850, 70-051285, 70-051779, 70-051779A, 70-052186, 70-052669, and 70-053022.
Patients and healthcare providers who received these kits should consult with their healthcare provider immediately. Do not use affected units if sterilization cannot be verified.
The recalled product
- Product
- GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- infection-risk
- functionality-loss
- treatment-delay
Distribution
Distributed nationwide across the United States.
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