Recall Z-3240-2024— American Contract Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2024-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit. Reason: 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..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-07
- Firm location
- Kansas City, MO, United States
Product description
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.