| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01580-1 |
| Product Name/Description |
Atrium Chest Drains
Ocean Drains
Model Numbers: 2002-300, 2012-320, 2050-300
Oasis Drains
Model Numbers: 3600-100, 3612-100, 3612-100, 3620-100
Express Drains
Model Numbers: 4000-100N, 40120-100N
Express Mini
Model Number: 16400
All Lot Numbers with Expiration Date Prior to October 2019
ARTG Number: 119726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Atrium chest drainage products are packaged with a double sequential sterile wrap and placed into an outer dust cover. The dust cover is folded over and secured with the package label. The label on the outer package denotes the product as being sterile. The chest drain inside the packaging is sterile; the outer dust cover is not sterile. The two sterilisation wraps are what provide the sterile barrier for the product. This packaging system is the same configuration used on Atrium chest drainage products for the past 30 years. Maquet is providing users with clarification as to which part of the packaged drain is sterile. In addition, Maquet is advising that product manufactured after October 18 2016 will contain a new warning label that identifies the pouch as not being a sterile barrier and warns the user that only the chest drain can be entered into the sterile field. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is informing users of the following steps for introduction of the Atrium Chest Drains into the sterile field;
To introduce the chest drain into the sterile field:
1. Remove the wrapped chest drain from the dust cover.
2. Open the 2 sterilisation wraps using sterile technique.
3. Only enter the chest drain into the sterile field.
Maquet is also providing the new warning label that product manufactured from October 18 2016 will contain, and is requesting users to post copies of this label near all Atrium chest drain product inventory with expiration date prior to October 2019. This action has been closed-out on 26/05/2017. |
| Contact Information |
02 8874 3100 - Maquet |