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- Starting date:
- July 31, 2017
- Posting date:
- September 5, 2017
- 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-64392
Reason
Baxter is issuing a recall for a specific product code and lot number due to the potential presence of leaks. A leak may allow for microbial contamination of the sterile fluid path. If not detected, the use of a bag with leak could lead to a bloodstream infection or other serious adverse health consequences. There have been no reports of adverse events associated with this issue for leaks.
Affected products
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Lot or serial number
DR16J18096
Model or catalog number
2J8003
Companies
- Manufacturer
-
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield
60015
Illinois
UNITED STATES