| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00284-1 |
| Product Name/Description |
CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)
CBCII AMBULATING BULB (PK10)
Catalogue Number: 0225028852
Lot Numbers: 10337012, 10281012
1/8 TROCAR W/DRAIN (PK10)
Catalogue Number: 0215018000
Lot Numbers: 13191012, 11088012,11125012, 11204012
1/4 TROCAR W/DRAIN (PK10)
Catalogue Number: 0215019000
Lot Number: 12235012
ARTG Numbers: 140544, 233315 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer have identified that the boxes used to ship the products were too small for the number of products (10 units) packaged within the box. The units packed into the shipper experienced bending and folding of the pouches. This can increase the risk of breaching the outer pouch. Note that only a breach in the exterior pouch was detected – the interior pouch was not breached. A breach would have to develop in both pouches before the product would become unsterile. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is requesting their customer to discontinue use and quarantine the affected product. A Stryker Representative will organise for the removal of any affected units found and a credit will be given for these items.
This action has been closed out on the 17/10/2018. |
| Contact Information |
1800 803 601 - Stryker Australia |