Health product recall

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