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BIOMET GPS PLATELET CONCENTRATE KITS (2016-07-15)
- Starting date:
- July 15, 2016
- Posting date:
- July 29, 2016
- 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-59622
Affected products
- PLASMAX W/ GPS III MINI CONCENTRATE KIT
- GPS III MINI PLATELET CONCENTRATE KIT
- GPS III PLATELET CONCENTRATE KIT
Reason
Biomet biologics has initiated a recall of various kits which contain defective ACD-A 30ml vials. These vials may have a split finish, which occurs during the glass bottle manufacturing process. This defect could compromise product sterility. The risk of sterility breach is estimated as rare, less than 1%, and the risk of injury to patients is remote, less than 0.1%.
Affected products
A. PLASMAX W/ GPS III MINI CONCENTRATE KIT
Lot or serial number
- 400403
Model or catalog number
- 800-0516
Companies
- Manufacturer
-
BIOMET BIOLOGICS, INC.
56 EAST BELL DRIVE, P.O. BOX 587
WARSAW
46581
Indiana
UNITED STATES
B. GPS III MINI PLATELET CONCENTRATE KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 800-0505A
- 800-0670A
Companies
- Manufacturer
-
BIOMET BIOLOGICS, INC.
56 EAST BELL DRIVE, P.O. BOX 587
WARSAW
46581
Indiana
UNITED STATES
C. GPS III PLATELET CONCENTRATE KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 800-0675A
- 800-1003A
Companies
- Manufacturer
-
BIOMET BIOLOGICS, INC.
56 EAST BELL DRIVE, P.O. BOX 587
WARSAW
46581
Indiana
UNITED STATES