MICRO-FLO, HAEMO-FLO AND MINI-FLO PRODUCTS (2021-04-01)
- Starting date:
- April 1, 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-76009
Last updated:
2021-07-13
Affected Products
A. MICRO-FLO
B. HAEMO-FLO BLOOD DRAWING SETS MICRO-BORE PVC DOP (DEHP) FREE TUBING
C. HAEMO-FLO SAFE+
D. MINI-FLO SAFE
Reason
Products not correctly sterilized by the supplier's own admission dated 2021-02-22. Some sterilisation certificates have been fraudulently falsified at the Steril Milano sterilisation plant.
Affected products
A. MICRO-FLO
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
F.M. S.P.A.
Via Farini 65/Bis
Cigliano Vc
ITALY
B. HAEMO-FLO BLOOD DRAWING SETS MICRO-BORE PVC DOP (DEHP) FREE TUBING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HA2104
HA2304
Companies
- Manufacturer
-
F.M. S.P.A.
Via Farini 65/Bis
Cigliano Vc
ITALY
C. HAEMO-FLO SAFE+
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HAN 2324P
Companies
- Manufacturer
-
F.M. S.P.A.
Via Farini 65/Bis
Cigliano Vc
ITALY
D. MINI-FLO SAFE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ASN2127P
ASN2327P
Companies
- Manufacturer
-
F.M. S.P.A.
Via Farini 65/Bis
Cigliano Vc
ITALY