Surgical convenience kit sterilization assurance cannot be confirmed
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
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 Class II FDA recall of a surgical medical device with unconfirmed sterilization due to manufacturing control failure. No illnesses or injuries have been reported. Per the rubric, Class II recalls without reported hospitalization or injury fall at the High (Score 3) level when the hazard is theoretical—unconfirmed sterilization is a risk-of-harm situation without confirmed adverse events.
Plain-English summary
American Contract Systems, Inc. is recalling the Essentia MAJ Laparotomy Std Pack (model ESLT53B), a medical convenience kit. Due to an inoperable chart recorder during manufacturing, humidity readings in one controlled environment area were out-of-specification.
Because of this manufacturing control failure, the company cannot confirm that product sterilization assurance requirements were met. Sterilization is critical for surgical medical devices and convenience kits used in medical procedures.
The recall affects 68 units distributed nationwide in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. The affected lot is 2405102, expiring May 10, 2025 (UDI-DI: 00191072218438).
The recalled product
- Product
- Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 68
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: 00191072218438
- Lot: 2405102
- Exp: 05/10/2025
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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