Cell Saver 5 - Fast Pack, Cell Saver Elite Processing Set & Cell Saver Elite Fastpack (2019-10-18)
- Starting date:
- October 18, 2019
- Posting date:
- November 8, 2019
- 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-71545
Last updated: 2019-11-08
Affected Products
- Cell Saver 5 - Fast Pack
- Cell Saver 5 - Packs
- Cell Saver Elite Processing Set
- Cell Saver Elite Fastpack
Reason
There is a potential issue with Cell Saver 5/5+ and Cell Saver Elite/Elite+ 125ml and 225ml bowl sets. A small number of bowl sets may have the potential to develop leaks at the inner core, which could result in fluid becoming trapped inside the bowl core, causing a "long empty" device error message with the possibility of incomplete washing.
Affected products
A. Cell Saver 5 - Fast Pack
Lot or serial number
All lots.
Model or catalog number
- 00260-00
- 00265-00
- 0260F-00
- 0265F-00
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES
B. Cell Saver 5 - Packs
Lot or serial number
All lots.
Model or catalog number
00261-00
00263-00
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES
C. Cell Saver Elite Processing Set
Lot or serial number
All lots.
Model or catalog number
CSE-P-125
CSE-P-225
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES
D. Cell Saver Elite Fastpack
Lot or serial number
All lots.
Model or catalog number
CSE-FP-125V
CSE-FP-225F
CSE-FP-225V
Companies
- Manufacturer
-
Haemonetics Corporation
400 Wood Road
Braintree
02184
Massachusetts
UNITED STATES