Endovascular AAA Pack recalled for sterilization assurance failure
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
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 inability to confirm sterilization assurance due to a process control failure. Although no illnesses or injuries have been reported, the unconfirmed sterilization of a medical device creates a potential contamination risk, meeting the criterion for High severity.
Plain-English summary
The Endovascular AAA Pack, ESED52B, manufactured by American Contract Systems, Inc., is being recalled due to a failure in the sterilization assurance process. A malfunctioning chart recorder resulted in inability to confirm that humidity readings remained within specification in the controlled environment area during sterilization.
The recall affects 360 units distributed nationwide in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. The affected lot is 2405152 with an expiration date of 05/15/2025. Lot-specific identification includes UDI-DI: 00191072198402.
Healthcare facilities that have received units from this lot should not use the affected devices and should contact American Contract Systems for return or replacement instructions.
The recalled product
- Product
- Endovascular AAA Pack, ESED52B; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 360
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 (3)
- UDI-DI: 00191072198402
- Lot: 2405152
- Exp: 05/15/2025
Distribution
Part of a larger recall action
This product is one of 19 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 19 products in this recall →Related recalls
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