Agency classClass IIOur severity:High FDA (Devices)·Z-1038-2022·Announced 2022-05-18

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.

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 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
Affected units: 24

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.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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