Essentia MAJ Laparotomy Std Pack recall
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Why was Essentia MAJ Laparotomy Std Pack recalled?
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00191072218438; Lot: 2405102; Exp: 05/10/2025
- Product
- Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 68 units
- Distribution
- US Nationwide distribution in the states of MO, MN, MA, OH, NE.
- Recall date
- October 2, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)