ACS IR Angio Pack Sterilization Process Defect Recall
The ACS IR Angio Pack from American Contract Systems, Inc. was sterilized using ethylene oxide at higher than specification concentration. No illnesses or injuries have been reported.
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 is a FDA Class II medical device recall involving a sterilization process defect (higher than specification ethylene oxide concentration). While sterilization defects in medical devices pose a risk of harm to patients, no illnesses or injuries have been reported.
Plain-English summary
American Contract Systems, Inc. is recalling the ACS IR Angio Pack, a medical device used in angiography procedures (Model JEIR37H, Lot 657211). The product was sterilized with ethylene oxide at a concentration higher than specified.
Proper sterilization is critical for medical devices. This sterilization process defect creates a potential risk when the device is used.
Affected units were distributed to Illinois, Missouri, Nebraska, and Texas. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ACS IR - Angio Pack
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Angiography
- Hazard
- sterilization-defect
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)
- Model JEIR37H
- Lot 657211 UDI: 00191072151612
Distribution
Distributed nationwide across the United States.
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