| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00509-1 |
| Product Name/Description |
Receptal System Liners and Canisters
All list numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
Through customer complaints, Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 2L liner or 3L liner with a 1.5L canister, which has resulted in a report of one death to date. There have been no reports of death or serious injury in Australia. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. Hospira advises users to not use incorrectly sized Receptal liners with Receptal canisters. All Receptal Liner and Canister List numbers are affected by this action. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is advising hospitals to only use the correct size liners are used with the corresponding canister and to ensure that the liner is fully extended in the liner. |
| Contact Information |
1300 046 774 - Hospira Customer Service |