Health product recall

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