Sodium Chloride Injection 0.9%, USP - Recall of Three Lots due to the Potential for Leakage of the Parenteral/intravenous Solution Bag

Starting date:
May 16, 2017
Posting date:
May 17, 2017
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
New safety information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-63324

Audience

Dialysis Unit Nephrologists, Nurses and Technicians; Home Hemodialysis Program Co-ordinators and affiliated staff admininstering this product in other settings if the product has been further distributed.

Key messages

  • Fresenius Medical Care Canada is recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 1000 mL due to the potential for leakage of the interior solution bag.
  • Leakage of a parenteral/intravenous solution bag for injection may result in a breach of sterility, microbial contamination, or air embolism from air introduced to the IV system.
  • Fresenius Medical Care Canada is advising all users to immediately locate and remove the affected lots from use and return all affected inventory to Fresenius Medical Care (1-888-709-4411). The affected lots should not be used.
  • Home hemodialysis programs should notify patients in their program about this recall without delay.

   

Issue

Fresenius has initiated a recall of 3 lots of 0.9% Sodium Chloride Injection USP, 1000 mL due to potential leakage of the parenteral/intravenous solution bag. Leakage of parenteral/intravenous solution bags may result in a breach of sterility, microbial contamination, or air embolism from air introduced to the IV system. If used in IV admixtures, there is potential for delivery of a more concentrated drug solution than intended.

These lots were distributed in Canada between Jan 04, 2017 and April 28, 2017.

Fresenius issued a recall notice on May 10, 2017.

Products affected

Products
Product
Name
Product code DIN Package format Lot
Numbers
Expiry date
0.9% Sodium Chloride Injection USP CNS-10109 02311798 1000 mL 16EU05011 May 31, 2017
16EU05012
16EU05013
16DU05064*
Apr 30, 2017

*A fourth lot (16DU05064) was also impacted but it has expired.

Background information

0.9% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes for fluid replenishment as required by the clinical condition of the patient and is labelled for IV use as a single dose. Unused portions should be discarded.  It is also used as a priming solution in hemodialysis procedures.   

Fresenius received complaints of leakage of the parenteral/intravenous solution bag of the specified lots; however, no adverse events have been reported. The root cause was determined to be a malfunction of one component of the bag making/sealing equipment. Fresenius has resolved the issue and product currently being shipped is not affected.

Who is affected

Information for home dialysis patients

Patients who have the affected lots in their homes should not use the affected lots and contact Fresenius Customer Service  at 1-888-709-4411 (choose Option #2) to arrange for replacement product and return of the affected bags.  Patients that only have the affected lot should also inform their health care provider.

Information for health care professionals

The specified solution lots should not be used. Please contact Fresenius Customer Service to arrange for return of the affected lots at 1-888-709-4411.

Healthcare professionals should also notify affiliated staff administering this product in other settings.

New information as of May 16, 2017:

Home hemodialysis programs should notify patients in their program about this recall without delay.  Fresenius has created a home patient letter describing the issue and steps to be taken by home patients and can distribute this notice on behalf of the clinic if requested to do so.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada is also monitoring the recall and the implementation of necessary corrective and preventive actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious blood infection or air embolism or other serious or unexpected side effects in patients receiving 0.9% Sodium Chloride Injection, 1000 mL should be reported to Fresenius Medical Care Canada or Health Canada.

Fresenius Medical Care Canada
Attn: Pharmacovigilance and Complaints
45 Staples Avenue, Suite 110
Richmond Hill, ON, L4B 4W6

To report an Adverse Reaction, health professionals and consumers may call toll free:
Phone: 1-888-709-4411 ext 3660
E-Mail: fmcccomplaints@fmc-ca.com
Fax: 1-905-770-2660

To correct your mailing address or fax number, contact Fresenius Medical Care Canada QA/RA at cndqara@fmc-ca.com.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or fax

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Regions Branch
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Sincerely,

Original signed by

Julie Kubien
Director, Quality and Regulatory Affairs
Fresenius Medical Care Canada Inc.

Images

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For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.