| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01011-1 |
| Product Name/Description |
Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits)
Affected kits:
BIOCUE STD KIT ACD-A W/BD
Product Number: 800-0613A
GPS3 SINGLE KIT W/BLOOD DRAW
Product Number: 800-0675A
GPS BONE BIOLOGICS KIT 20mL + S.TUBE
Product Number: TCP20GPSS.2
MARROWSTIM CALCIBON KIT 20mL
Product Number: TCP20MARROW
BIOCUE CALCIBON KIT 20mL
Product Number: TCP20BIOCUE
ARTG #: 183209, 100053, 127024 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has initiated this action following an investigation which identified a defect with the ACDA 30 ml vial known as a split finish that could compromise product sterility. Split finishes occur during the glass bottle manufacturing process. The data shows that the risk of a sterility breach is rare <1% and the risk of injury to patients is remote <0.1%. Use may result in an infection. There have been no reported complaints to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer Biomet is advising users inspect and quarantine affected stock for return. This action has been closed-out on 02/03/2017. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |