Various Products from Olsen Medical, LLC (2018-05-11)
- Starting date:
- May 11, 2018
- Posting date:
- June 22, 2018
- 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-67080
Affected products
A. Electrosurgical, Switch Pen, Disposable
B. Electrosurgical, Cable, Disposable
C. Electrosurgical, Monopolar Forceps, Disposable
D. Electrosurgical, Bipolar Forceps, Disposable
E. Irrigating Bayonet Forceps 7-1/8" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
F. Irrigating Bayonet Forceps 7-1/8" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
G. Irrigating Bayonet Forceps 7-1/8" 1.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
H. Irrigating Bayonet Forceps 8.25" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
I. Irrigating Bayonet Forceps 8.25" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
J. Irrigating Bayonet Forceps 8.25" 1.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
K. Irrigating Bayonet Forceps 10.5" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
L. Irrigating Bayonet Forceps 10.5" 1.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
M. Irrigating Bayonet Forceps 6" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
N. Irrigating Bayonet Forceps 6" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
O. Irrigating Bayonet Forceps 10.5" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
P. Integrated Irrigation Tubing and Bipolar Cord Set
Reason
On March 8th, 2018 symmetry surgical became aware through a customer complaint related to the Olsen Monopolar Pencil and Cord that some of the products may encroach into the sterile pouch seal, thereby, increasing the risk of the seal being compromised.
Affected products
A. Electrosurgical, Switch Pen, Disposable
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 75505
- 75530
- 75610
- 75800
- 75810
- 75820
- 95012
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
B. Electrosurgical, Cable, Disposable
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 40-1102
- 40-1103
- 40-1104
- 40-1113
- 40-1114
- 40-2106
- 40-2110
- 87500
- G-40-1102
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
C. Electrosurgical, Monopolar Forceps, Disposable
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-2650K
- 20-2920HK
- 20-2920K
- 20-2960HK
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
D. Electrosurgical, Bipolar Forceps, Disposable
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-1010KI
- 20-1030K
- 20-1040K
- 20-1040KI
- 20-1060K
- 20-1060KI
- 20-1070K
- 20-1070KI
- 20-1080KI
- 20-1082K
- 20-1082KI
- 20-1162KI
- 20-1190K
- 20-1190KI
- 20-1201K
- 20-1203KI
- 20-1315KI
- 20-1320K
- 20-1320KI
- 20-1325KI
- 20-1330K
- 20-1330KI
- 20-1340KI
- 20-1350KI
- 20-1360K
- 20-1360KI
- 20-1370K
- 20-1370KI
- 20-1375KI
- 20-1380K
- 20-1380KI
- 20-1382KI
- 20-1384KI
- 20-1386KI
- 20-1400K
- 20-1400KI
- 20-1410K
- 20-1415KI
- 20-1420K
- 20-1420KI
- 20-1440K
- 20-1440KI
- 20-1445K
- 20-1445KI
- 20-1480K
- 20-1480KI
- 20-1481K
- 20-1481KI
- 20-1486KI
- 20-1520KI
- 20-1535I
- 20-1550KI
- 20-1560KI
- 20-1570KI
- 20-1682KI
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
E. Irrigating Bayonet Forceps 7-1/8" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0361
- 20-0361G
- 20-0361R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
F. Irrigating Bayonet Forceps 7-1/8" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0371
- 20-0371R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
G. Irrigating Bayonet Forceps 7-1/8" 1.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0381
- 20-0381G
- 20-0381R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
H. Irrigating Bayonet Forceps 8.25" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0411
- 20-0411R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
I. Irrigating Bayonet Forceps 8.25" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0421
- 20-0421R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
J. Irrigating Bayonet Forceps 8.25" 1.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0431
- 20-0431G
- 20-0431R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
K. Irrigating Bayonet Forceps 10.5" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0481
- 20-0481R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
L. Irrigating Bayonet Forceps 10.5" 1.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0491
- 20-0491R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
M. Irrigating Bayonet Forceps 6" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
20-0321
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
N. Irrigating Bayonet Forceps 6" 1.0mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0331
- 20-0331R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
O. Irrigating Bayonet Forceps 10.5" 0.5mm Tips Electrosurgical/Irrigating BiPolar Forceps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20-0311
- 20-0311R
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES
P. Integrated Irrigation Tubing and Bipolar Cord Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 40-3001R
- 40-3003R-39
Companies
- Manufacturer
-
Olsen Medical, LLC
3230 Commerce Center Place
Louisville
40211
Kentucky
UNITED STATES