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Sleep Safe Sets (2016-12-08)
- Starting date:
- December 8, 2016
- Posting date:
- January 6, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-61638
Affected Products
A. Sleep Safe Set
B. Sleep Safe Set Plus
C. Sleep Safe Paed
Reason
An increased number of leakages were reported due to over welded coils on the patient and drainage lines. This led to difficulties in unrolling the tubing set causing damage to the lines and possibility of leakage.
Affected products
A. Sleep Safe Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5016921
Companies
- Manufacturer
-
Fresenius Medical Care AG & Co. KGAA
ELSE-KRONER-STRASSE 1
BAD HOMBURG
61352
GERMANY
B. Sleep Safe Set Plus
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5016931
Companies
- Manufacturer
-
Fresenius Medical Care AG & Co. KGAA
ELSE-KRONER-STRASSE 1
BAD HOMBURG
61352
GERMANY
C. Sleep Safe Paed
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5017391
Companies
- Manufacturer
-
Fresenius Medical Care AG & Co. KGAA
ELSE-KRONER-STRASSE 1
BAD HOMBURG
61352
GERMANY