Fresenius Medical Care expands recall of Sodium Bicarbonate Liquid Concentrate
- Starting date:
- April 9, 2014
- Posting date:
- April 9, 2014
- Type of communication:
- Information Update
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Contamination, Contamination
- Audience:
- General Public, General Public
- Identification number:
- RA-38977
Issue
Further to a public communication issued April 5, 2014, Fresenius Medical Care is expanding its voluntary recall (see list below) to include additional lots of "NaturaLyte Sodium Bicarbonate Liquid Concentrate" in 6.4L and 8L volumes. The recall of this product is due to bacterial contamination.
Health Canada will continue monitoring the recall and working with the company to help ensure patients and healthcare professionals are informed. Health Canada will also continue to provide updates to Canadians, as necessary.
Fresenius Medical Care has indicated to Health Canada that they are making every effort to expedite shipment of replacement product to customers and their patients.
Health Canada has posted advice for patients, hospitals and home patient programs.
| Products Code | Lot | Expiration |
|---|---|---|
| 08-4000-LB6.4 | 14AMLB013 | December 31, 2014 |
| 14AMLB014 | December 31, 2014 | |
| 14AMLB015 | December 31, 2014 | |
| 14AMLB016 | December 31, 2014 | |
| 14AMLB017 | December 31, 2014 | |
| 14BMLB001 | January 31, 2015 | |
| 13JMLB004 | June 30, 2014 | |
| 13JMLB006 | June 30, 2014 | |
| 13JMLB008 | June 30, 2014 | |
| 13JMLB005 | June 30, 2014 | |
| 13KMLB001 | July 31, 2014 | |
| 13KMLB002 | July 31, 2014 | |
| 13KMLB003 | July 31, 2014 | |
| 13KMLB004 | July 31, 2014 | |
| 13KMLB005 | July 31, 2014 | |
| 13KMLB007 | July 31, 2014 | |
| 13KMLB008 | July 31, 2014 | |
| 13KMLB009 | July 31, 2014 | |
| 13KMLB010 | July 31, 2014 | |
| 13KMLB011 | July 31, 2014 | |
| 13KMLB012 | July 31, 2014 | |
| 13KMLB013 | July 31, 2014 | |
| 13KMLB014 | July 31, 2014 | |
| 13KMLB015 | July 31, 2014 | |
| 13KMLB016 | July 31, 2014 | |
| 13LMLB001 | August 31, 2014 | |
| 13LMLB002 | August 31, 2014 | |
| 13LMLB003 | August 31, 2014 | |
| 13LMLB004 | August 31, 2014 | |
| 13LMLB005 | August 31, 2014 | |
| 13LMLB006 | August 31, 2014 | |
| 13LMLB007 | August 31, 2014 | |
| 13LMLB008 | August 31, 2014 | |
| 13LMLB009 | August 31, 2014 | |
| 13LMLB010 | August 31, 2014 | |
| 13LMLB011 | August 31, 2014 | |
| 13LMLB012 | August 31, 2014 | |
| 13LMLB014 | August 31, 2014 | |
| 13LMLB015 | August 31, 2014 | |
| 13LMLB016 | August 31, 2014 | |
| 14AMLB002 | December 31, 2014 | |
| 14AMLB003 | December 31, 2014 | |
| 14AMLB004 | December 31, 2014 | |
| 14AMLB005 | December 31, 2014 | |
| 14AMLB007 | December 31, 2014 | |
| 14AMLB008 | December 31, 2014 | |
| 14AMLB010 | December 31, 2014 | |
| 14AMLB012 | December 31, 2014 | |
| 08-4000-LB6.4T | 13LMLB013 | August 31, 2014 |
| 13KMLB006 | July 31, 2014 | |
| 08-4000-LB8 | 13JMLB007 | June 30, 2014 |
| 13KMLB017 | July 31, 2014 | |
| 14AMLB011 | December 31, 2014 |
Related AWRs
Media enquiries
Health Canada
(613) 957-2983
Public enquiries
(613) 957-2991
1-866 225-0709