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Haemonetics Plasma Collection System (2015-12-17)
- Starting date:
- December 17, 2015
- Posting date:
- January 14, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56630
Affected Products
A. Plasma Collection System 2
B. MCS+LN9000 Centrifugal Blood Cell Separator
C. MCS+LN8150 (SW Rev.F)
D. ACP215 System
Reason
Haemonetics has become aware of customers using harsh chemicals to clean the pump rotor assembly. Improper cleaning may damage the pump rollers leading to device malfunction.
Affected products
A. Plasma Collection System 2
Lot or serial number
All serial numbers.
Model or catalog number
- 06002-110-EXP-EW
- 06002-CP-110
- 06002-CP-NA
- 06002-CPL-110
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES
B. MCS+LN9000 Centrifugal Blood Cell Separator
Lot or serial number
All serial numbers.
Model or catalog number
- 09000-110-E
- 09000-110-EWC
- 9000-110-ED
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES
C. MCS+LN8150 (SW Rev.F)
Lot or serial number
All serial numbers.
Model or catalog number
MCS+LN8150
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES
D. ACP215 System
Lot or serial number
All serial numbers.
Model or catalog number
02215-110-E
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES