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Ocean, Oasis and Express Chest Drains (2016-12-09)
- Starting date:
- December 9, 2016
- Posting date:
- January 6, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61700
Affected Products
A. Ocean Chest Drain
B. Oasis Chest Drain
C. Express Chest Drain
D. Express Mini 500 Chest Drain
Reason
To provide clarification about the packaging configuration of the products. Products are packaged with a double sequential sterile wrap and placed into an outer dust cover. The dust cover is 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 but the outer dust cover is not sterile.
Affected products
A. Ocean Chest Drain
Lot or serial number
Lots expiring before Oct. 2019
Model or catalog number
2002-000
2002-100
2002-300
2002-400
2012-320
2050-000
Companies
- Manufacturer
-
Atrium Medical Corporation
5 Wentworth Drive
Hudson
03051
New Hampshire
UNITED STATES
B. Oasis Chest Drain
Lot or serial number
Lots expiring before Oct. 2019
Model or catalog number
3600-100
3612-100
3612-400
3620-100
3650-100
Companies
- Manufacturer
-
Atrium Medical Corporation
5 Wentworth Drive
Hudson
03051
New Hampshire
UNITED STATES
C. Express Chest Drain
Lot or serial number
Lots expiring before october 2019
Model or catalog number
4000-100N
4020-100N
Companies
- Manufacturer
-
Atrium Medical Corporation
5 Wentworth Drive
Hudson
03051
New Hampshire
UNITED STATES
D. Express Mini 500 Chest Drain
Lot or serial number
Lots expiring before Oct. 2019
Model or catalog number
16400
Companies
- Manufacturer
-
Atrium Medical Corporation
5 Wentworth Drive
Hudson
03051
New Hampshire
UNITED STATES