Public recall detail

Baxter Intravenous Solution Bags – Potential Leak During Spiking of Administration Port

2023-10-06

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Recall Safety notice
Quick summary

Quick summary: Baxter Intravenous Solution Bags – Potential Leak During Spiking of Administration Port. Date: 2023-10-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Baxter Intravenous Solution Bags – Potential Leak During Spiking of Administration Port. Date: 2023-10-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand
Product0.4% Lidocaine & 5% Dextrose Injection, 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP, and Metronidazole Injection, USP
IssueHealth products - Product quality Health products - Product safety
IdentificationRA-74389

Affected products

ProductProduct Name
DIN / NPN / authorizationMarket Authorization Holder
LotLot Numbers/ Expiration Dates of products not recalled
SizePackage Size
CodesProduct Code
Affected datesLot Numbers/ Expiration Dates of products not recalled
Product0.4% Lidocaine & 5% Dextrose Injection
DIN / NPN / authorizationBaxter Corporation
LotSee Appendix A
Size250 mL
CodesJB0972
Affected datesSee Appendix A
Product0.9% Sodium Chloride Injection, USP
DIN / NPN / authorizationBaxter Corporation
LotSee Appendix A
Size100 mL 250 mL
CodesJB1302 JB1322
Affected datesSee Appendix A
ProductLactated Ringer’s Injection, USP
DIN / NPN / authorizationBaxter Corporation
LotSee Appendix A
Size250 mL
CodesJB2322
Affected datesSee Appendix A
ProductMetronidazole Injection, USP
DIN / NPN / authorizationBaxter Corporation
LotSee Appendix A
Size100 mL
CodesJB3415
Affected datesSee Appendix A

What you should do

  • See Key Messages below
Additional official information
AudienceHealth professionals
CategoryHealth products
CompaniesPublished by Health Canada
Published byHealth Canada
Alert / recall typeHealth professional risk communication
Identification numberRA-74389
Background{"text":"There have been reports of leaks and/or disconnections observed during spiking on the administration port at the connection of the lower tubing section and the main port tube (see Appendix B as an example). Baxter identified the cause of the leakage of these intravenous bags as a combination of factors related to the manufacturing process. Baxter has implemented appropriate measures to address the leaks and prevent reoccurrence. Products from the affected lots were distributed by Baxter Corporation in Canada beginning April 28, 2023. The safety risks that could occur because of a leaking solution bag include: Delay or interruption in therapy resulting in the administration of an inaccurate dose. Healthcare professionals or patients being exposed to the drug product, including hazardous medications (e.g., cytotoxic chemotherapeutic drugs) when these medications have been added to the bags. Patients receiving an infusion of contaminated solution due to microbial contamination of the solution at the point of use. Healthcare professionals or patients being exposed to harm due to the solution leaking onto electrical equipment. Baxter is taking a phased-in recall approach to prevent a product shortage. In consultation with Health Canada, the affected lots identified in Appendix A are not being recalled at this time to ensure the continued availability of these medically necessary products. Further market actions may be taken in the future once sufficient non affected supply is available. Baxter has previously initiated similar recalls of products affected by this issue, in consultation with Health Canada. For additional details, consult the Recalls and Safety Alerts Database on the Healthy Canadians Web Site."}
CompaniesPublished by Health Canada
AudiencesHealth professionals
Source updated2023-10-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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