DISPOSABLE BIPOLAR ABLATOR, ASPIRATING & NON-ASPIRATING (2021-02-01)
- Starting date:
- February 1, 2021
- Posting date:
- March 11, 2021
- 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-75093
Last updated: 2021-03-11
Affected Products
A. DISPOSABLE BIPOLAR ABLATOR, ASPIRATING
B. DISPOSABLE BIPOLAR ABLATOR, NON-ASPIRATING
Reason
Package integrity failure leading to potential breach of the sterile barrier and potential contamination of the sterile product inside packaging. There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. Issue was discovered after worst case transportation / handling / shipping/extreme temperature conditions showed package integrity failure in 10.5% of samples tested.
Affected products
A. DISPOSABLE BIPOLAR ABLATOR, ASPIRATING
Lot or serial number
SN# C3350A LOT# 0517D
SN# C3390A LOT# 0517D
Model or catalog number
C3350A
C3390A
Companies
- Manufacturer
-
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater
33760
Florida
UNITED STATES
B. DISPOSABLE BIPOLAR ABLATOR, NON-ASPIRATING
Lot or serial number
SN# C1860NA LOT# 0817H
SN# C2455NA LOT# 0817H
SN# C3350NA LOT# 0817H
SN# C3390NA LOT# 0817H
Model or catalog number
C1860NA
C2455NA
C3350NA
C3390NA
Companies
- Manufacturer
-
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater
33760
Florida
UNITED STATES