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.
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: 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
- Affected units
- 956
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems 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.
See all 32 products in this recall →Related recalls
Same manufacturer · American Contract Systems Inc
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighAngiography Packs Recalled Due to Sterilization Validation Failure
FDA (Devices) · 2022-09-14
- HighAngiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation
FDA (Devices) · 2022-09-14
- HighLaparoscopy surgical instrument packs recalled for sterilization validation failure
FDA (Devices) · 2022-09-14
- HighBiopsy and laparoscopy packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighGyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process
FDA (Devices) · 2024-08-14
- HighLaparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements
FDA (Devices) · 2025-09-03