| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00167-1 |
| Product Name/Description |
SANDEL Weighted Safety Scalpels
Catalogue numbers: 2210-N, 2211-N, 2215-N, 2220-N, 2210-L, 2211-L & 2215-L
ARTG number: 196914 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
In November of 2013 Ansell Limited undertook a recall of a number of specific batches of some of the product codes for the above product. TGA Recall RC-2013-RN-01152-1 refers. This recall was closed out by the TGA on 13 February 2015.
As an interim corrective action, both the overseas manufacturer and Ansell Limited in California implemented a 100% visual inspection of all product prior to shipping from our warehouse to prevent recurrence of the problem of the safety shield moving and the blade tip being exposed.
Subsequently, one customer complaint has been received of a user receiving an injury from an exposed blade tip while picking up the scalpel from the dispenser pack. This was a scalpel not originating from any identified lot of product from the original recall.
Upon inspecting warehouse stock, we have further identified a small number of scalpels where the blade tip has become exposed. These were all found before the product was shipped to distributors or customers |
| Recall Action |
Recall |
| Recall Action Instructions |
Ansell is requesting users to quarantine affected lots and return to Ansell for replacement or credit. This action has been closed-out on 1/06/2016. |
| Contact Information |
1800 337 041 - Ansell Customer Service Department |