Agency classClass IIOur severity:High FDA (Devices)·Z-1689-2022·Announced 2022-09-14

Angiography Packs Recalled Due to Sterilization Validation Failure

American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.

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 medical device recall involving angiography packs used in invasive procedures where sterility is critical. The sterilization validation failure represents a risk-of-harm product. No illnesses or injuries have been reported, which limits the score to a maximum of 3 per the rubric criteria for theoretical hazards without reported harm.

Plain-English summary

American Contract Systems, Inc. is recalling 57 angiography packs and trays distributed to health systems and distributors. The affected products were distributed to facilities in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.

The recall was initiated because the sterilization process used on these devices was not validated for multiple sterilization cycles. When medical devices are exposed to sterilization procedures without proper validation for repeated exposures, their sterility integrity may be compromised, potentially increasing the risk of infection during invasive angiography procedures.

Healthcare facilities and distributors that received these angiography packs should contact American Contract Systems, Inc. for guidance on the affected units and appropriate remedial actions.

The recalled product

Product: Various Angiography packs/trays
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Angiography / Interventional
Hazard: sterilization-failure
sterile-integrity-compromise
infection-risk
Affected units: 57

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 (20)

Tray Number
Sterilization Lot
Lot Number
and Bag Serial Number: 1) LSRARTDATANGA
2105051
884211
44136929 2) LSRANGIRM21G
2105111
874211
63991913 3) LSRCFHANGD
2106031
854211
14887381 4) LSRARTDATANGA
2107102
821211
44256256 5) LSRARTDATANGA
44256255 6) LSRARTDATANGA
2110011
742211
44373255 7) LSRARTDATANGA

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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Same hazard · sterilization failure