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BIOMET GPS PLATELET CONCENTRATE KITS (2016-07-15)

Report a Concern
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

  1. PLASMAX W/ GPS III MINI CONCENTRATE KIT
  2. GPS III MINI PLATELET CONCENTRATE KIT
  3. 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