American Contract Systems, Inc. recalls Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenien
Recalled Product
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Hazard / Issue
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.
Issued by
FDA
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