Health product recall

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

  1. Cell Saver 5 - Fast Pack
  2. Cell Saver 5 - Packs
  3. Cell Saver Elite Processing Set
  4. 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