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BodyGuard 323 Infusion Pump (2015-01-26)
- Starting date:
- January 26, 2015
- Posting date:
- February 16, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43737
Recalled Products
A) BodyGuard 323 Infusion Pump
Reason
CME America has identified a software issue with the bodyguard 323 that results in an over-infusion of medication without alarm. For the over-infusion to occur, specific set-up conditions must exist at the same time. Serious injuries and/or deaths could occur due to the failure mode associated with this recall.
Affected products
A) BodyGuard 323 Infusion Pump
Lot or serial number
S/N 69370
S/N 71309
S/N 71329
S/N 71462
Model or catalog number
BODYGUARD 323
Companies
- Manufacturer
-
Caesarea Medical Electronics Ltd.
16 Shacham Street, Industrial Park P. O. Box 4294
Caesarea
38900
ISRAEL