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Ocean Blood Recovery Systems (2013-11-22)
- Starting date:
- November 22, 2013
- Posting date:
- January 6, 2014
- 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-37259
Recalled products
- Ocean 2050 Blood Recovery
- Oasis 3650 Blood Recovery
Reason
Atrium Medical has become aware that the force required to detach the tubing from the drain may be lower than product specifications. It has come to Atrium's attention that some customers (3) have experienced leakage of blood or disconnection of the drain at the connection point of the ATS access line and the chest drain.
Affected products
A. Ocean 2050 Blood Recovery
Lot or serial number
- 10887456
- 10895182
Model or catalog number
- 2050-070
Companies
- Manufacturer
-
Atrium Medical Corporation
5 Wentworth Drive
Hudson
03051
New Hampshire
UNITED STATES
B. Oasis 3650 Blood Recovery
Lot or serial number
- 10891217
- 10905010
Model or catalog number
- 3650-100
Companies
- Manufacturer
-
Atrium Medical Corporation
5 Wentworth Drive
Hudson
03051
New Hampshire
UNITED STATES