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MPS Delivery Set (2015-10-29)
- Starting date:
- October 29, 2015
- 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-55974
Affected Products
A. MPS Delivery Set w/arrest agent and additive cassette
B. MPS Delivery Set
Reason
The identified lots of MPS Delivery Sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery.
Affected products
A. MPS Delivery Set w/arrest agent and additive cassette
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5001102
Companies
- Manufacturer
-
Quest Medical, Inc.
ONE ALLENTOWN PARKWAY
Allen
75002
Texas
UNITED STATES
B. MPS Delivery Set
Lot or serial number
0492205E03
0492765E07
0493695U04
0494485U07
0495965G04
0497265S02
049925G02
Model or catalog number
5001102AS
7001102
Companies
- Manufacturer
-
Quest Medical, Inc.
ONE ALLENTOWN PARKWAY
Allen
75002
Texas
UNITED STATES