Plasma Collection System 2 & PCS2 (2020-04-09)
- Starting date:
- April 9, 2020
- Posting date:
- May 22, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73147
Last updated: 2020-05-22
Affected Products
A. Plasma Collection System 2
B. PCS2
Reason
This action is a correction to the device labeling (user manual). The device itself is not defective.
We have identified that the calculation for volume of anticoagulant (AC) in the apheresis plasma product provided in revision AA of the PCS2 user manual does not account for approximately 9ml of AC that is present in the disposable set after priming the tubing at the start of a procedure.
Affected products
A. Plasma Collection System 2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
06002-110-EXP-EW
06002-CP-110
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES
B. PCS2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
06002-110-EXP-EW
06002-110-NA
06002-CP-110
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES