Endovascular AAA Packs Recalled Due to Sterilization Process Defect
American Contract Systems is recalling 93 units of Endovascular AAA Packs due to inability to confirm sterilization assurance requirements were met following an environmental monitoring failure.
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: FDA Class II recall of a surgical implant device with inability to confirm sterilization assurance. No illnesses or injuries have been reported, but the product represents a potential risk of harm given its use as a surgical implant.
Plain-English summary
American Contract Systems, Inc. is recalling 93 units of the Endovascular AAA Pack, ESED52B, a medical convenience kit used in endovascular procedures.
The recall was issued because an inoperable chart recorder prevented adequate monitoring of humidity levels in a controlled environment area during the manufacturing process. Humidity readings fell outside acceptable specifications, and the manufacturer cannot confirm that product sterilization assurance requirements were met.
The product was distributed nationwide to facilities in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. The affected lot is 2405153 with expiration 05/15/2025 (UDI-DI: 00191072218339).
The recalled product
- Product
- Endovascular AAA Pack, ESED52B; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Endovascular
- Affected units
- 93
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: 00191072218339
- Lot: 2405153
- 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.
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