MUST KIT PLUS (2021-04-09)
- Starting date:
- April 9, 2021
- Posting date:
- July 13, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-76021
Last updated:
2021-07-13
Affected Products
MUST KIT PLUS
Reason
Steril Milano is a contract sterilizer for Ethylene Oxide sterilization of Sidam. The quality issue detected by Steril Milano, during an internal audit, is due to the falsification of the cycle graphs and the manual editing of the treatment certificates in order to make them match with the new graphs associated to the cycles.
Affected products
MUST KIT PLUS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
640250
640473
Companies
- Manufacturer
-
SIDAM S.R.L.
Via Statale Sud, 169
San Giacomo Roncole - Mirandola
ITALY