Various products from Medos International Sàrl (2018-03-01)
- Starting date:
- March 1, 2018
- Posting date:
- April 13, 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-66440
Affected products
- PRESIDIO Microcoils
- CASHMERE PLATINUM Microcoils
- EnPower Detachment Control Box
- CASHMERE CERECYTE Microcoils
- DELTAPAQ PLATINUM Microcoils
- DELTAPAQ CERECYTE Microcoils
- MICRUSPHERE PLATINUM Microcoils
- DETACHMENT CONTROL BOX
- ULTIPAQ PLATINUM Microcoils
- HELIPAQ 10 PLATINUM Microcoils
- HELIPAQ 18 PLATINUM Microcoils
- ULTIPAQ CERECYTE Microcoils
- HELIPAQ CERECYTE Microcoils
- MICRUSPHERE CERECYTE Microcoils
- MICRUSPHERE PLATINUM LONGER Microcoils
- DELTAPLUSH CERECYTE Microcoils
- DELTAPLUSH PLATINUM Microcoils
- MICRUSPHERE XL 10 PLATINUM Microcoils
- MICRUSPHERE XL 18 PLATINUM Microcoils
- ORBIT GALAXY G2 Detachable Coil - CX
- ORBIT GALAXY G2 Detachable Coils - HX
- ORBIT GALAXY G2 Detachable Coils - CF
- DELTAMAXX Platinum Microcoils
- DELTAMAXX CERECYTE Microcoils
Reason
DePuy Synthes is launching a new line of spectra embolic Microcoil’s with a new detachment control box. This Field Safety Notice (FSN) is being issued because there are risks to using the current and new generation products together. The current generation of CODMAN Embolic Microcoil Systems and detachment control boxes are being removed from the market.
Affected products
A. PRESIDIO Microcoils
Lot or serial number
All lots.
Model or catalog number
- PC4100412-30
- PC4100517-30
- PC4100521-30
- PC4100626-30
- PC4100730-30
- PC4100829-30
- PC4180830-30
- PC4180933-30
- PC4181034-30
- PC4181137-30
- PC4181240-30
- PC4181343-30
- PC4181447-30
- PC4181550-30
- PC4181647-30
- PC4181750-30
- PC4181846-30
- PC4181950-30
- PC4182050-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
B. CASHMERE PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- SRC140225-20
- SRC140303-20
- SRC140304-20
- SRC140305-20
- SRC140306-20
- SRC140406-20
- SRC140407-20
- SRC140408-20
- SRC140445-20
- SRC140507-20
- SRC140509-20
- SRC140510-20
- SRC140512-20
- SRC140609-20
- SRC140611-20
- SRC140612-20
- SRC140615-20
- SRC140711-20
- SRC140713-20
- SRC140715-20
- SRC140717-20
- SRC140812-20
- SRC140815-20
- SRC140817-20
- SRC140820-20
- SRC140914-20
- SRC140917-20
- SRC140920-20
- SRC140922-20
- SRC141016-20
- SRC141019-20
- SRC141022-20
- SRC141025-20
- SRC141118-20
- SRC141122-20
- SRC141125-20
- SRC141127-20
- SRC141219-20
- SRC141223-20
- SRC141227-20
- SRC141230-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
C. EnPower Detachment Control Box
Lot or serial number
All lots.
Model or catalog number
- DCB000005-00
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
D. CASHMERE CERECYTE Microcoils
Lot or serial number
All lots.
Model or catalog number
- CRC140225-30
- CRC140303-30
- CRC140304-30
- CRC140305-30
- CRC140306-30
- CRC140406-30
- CRC140407-30
- CRC140408-30
- CRC140445-30
- CRC140507-30
- CRC140509-30
- CRC140510-30
- CRC140512-30
- CRC140609-30
- CRC140611-30
- CRC140612-30
- CRC140615-30
- CRC140711-30
- CRC140713-30
- CRC140715-30
- CRC140717-30
- CRC140812-30
- CRC140815-30
- CRC140817-30
- CRC140820-30
- CRC140914-30
- CRC140917-30
- CRC140920-30
- CRC140922-30
- CRC141016-30
- CRC141019-30
- CRC141022-30
- CRC141025-30
- CRC141118-30
- CRC141122-30
- CRC141125-30
- CRC141127-30
- CRC141219-30
- CRC141223-30
- CRC141227-30
- CRC141230-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
E. DELTAPAQ PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- DFS100151-20
- DFS100152-20
- DFS100153-20
- DFS100154-20
- DFS100156-20
- DFS100201-20
- DFS100202-20
- DFS100203-20
- DFS100204-20
- DFS100206-20
- DFS100208-20
- DFS100210-20
- DFS100250-20
- DFS100252-20
- DFS100254-20
- DFS100256-20
- DFS100258-20
- DFS100302-20
- DFS100304-20
- DFS100306-20
- DFS100308-20
- DFS100310-20
- DFS100402-20
- DFS100404-20
- DFS100406-20
- DFS100408-20
- DFS100410-20
- DFS100506-20
- DFS100508-20
- DFS100510-20
- DFS100515-20
- DFS100606-20
- DFS100608-20
- DFS100610-20
- DFS100612-20
- DFS100616-20
- DFS100710-20
- DFS100712-20
- DFS100716-20
- DFS100720-20
- DFS100810-20
- DFS100812-20
- DFS100816-20
- DFS100820-20
- DFS100915-20
- DFS100920-20
- DFS100925-20
- DFS101015-20
- DFS101020-20
- DFS101025-20
- DFS102510-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
F. DELTAPAQ CERECYTE Microcoils
Lot or serial number
All lots.
Model or catalog number
- CDF100151-30
- CDF100152-30
- CDF100153-30
- CDF100154-30
- CDF100156-30
- CDF100201-30
- CDF100202-30
- CDF100203-30
- CDF100204-30
- CDF100206-30
- CDF100208-30
- CDF100210-30
- CDF100250-30
- CDF100252-30
- CDF100254-30
- CDF100256-30
- CDF100258-30
- CDF100302-30
- CDF100304-30
- CDF100306-30
- CDF100308-30
- CDF100310-30
- CDF100402-30
- CDF100404-30
- CDF100406-30
- CDF100408-30
- CDF100410-30
- CDF100506-30
- CDF100508-30
- CDF100510-30
- CDF100515-30
- CDF100606-30
- CDF100608-30
- CDF100610-30
- CDF100612-30
- CDF100616-30
- CDF100710-30
- CDF100712-30
- CDF100716-30
- CDF100720-30
- CDF100810-30
- CDF100812-30
- CDF100816-30
- CDF100820-30
- CDF100915-30
- CDF100920-30
- CDF100925-30
- CDF101015-30
- CDF101020-30
- CDF101025-30
- CDF102510-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
G. MICRUSPHERE PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- HEL100202-20
- HEL100204-20
- HEL100206-20
- HEL100208-20
- HEL100304-20
- HEL100306-20
- HEL100308-20
- HEL100310-20
- HEL100404-20
- HEL100406-20
- HEL100408-20
- HEL100410-20
- HEL100510-20
- HEL100515-20
- HEL100520-20
- HEL100610-20
- HEL100615-20
- HEL100620-20
- HEL100710-20
- HEL100715-20
- HEL100720-20
- HEL100730-20
- HEL100810-20
- HEL100815-20
- HEL100820-20
- HEL100830-20
- HEL100915-20
- HEL100920-20
- HEL100930-20
- HEL101015-20
- HEL101020-20
- HEL101030-20
- SPH100200-20
- SPH100250-20
- SPH100300-20
- SPH100350-20
- SPH100400-20
- SPH100500-20
- SPH100600-20
- SPH100700-20
- SPH100800-20
- SPH100900-20
- SPH101000-20
- SPH101200-20
- SPH180200-20
- SPH180300-20
- SPH180400-20
- SPH180500-20
- SPH180600-20
- SPH180700-20
- SPH180800-20
- SPH180900-20
- SPH181000-20
- SPH181100-20
- SPH181200-20
- SPH181300-20
- SPH181400-20
- SPH181500-20
- SPH181600-20
- SPH181700-20
- SPH181800-20
- SPH181900-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
H. DETACHMENT CONTROL BOX
Lot or serial number
All lots.
Model or catalog number
- CCB000157-00
- CCB000262-20
- DCB000001-20
- ECB000182-00
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
I. ULTIPAQ PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- FSR100201-20
- FSR100202-20
- FSR100203-20
- FSR100204-20
- FSR100206-20
- FSR100208-20
- FSR100252-20
- FSR100254-20
- FSR100256-20
- FSR100258-20
- FSR100302-20
- FSR100304-20
- FSR100306-20
- FSR100308-20
- FSR100402-20
- FSR100404-20
- FSR100406-20
- FSR100408-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
J. HELIPAQ 10 PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- HSR100201-20
- HSR100202-20
- HSR100203-20
- HSR100204-20
- HSR100206-20
- HSR100208-20
- HSR100304-20
- HSR100306-20
- HSR100308-20
- HSR100310-20
- HSR100404-20
- HSR100406-20
- HSR100408-20
- HSR100410-20
- HSR100510-20
- HSR100515-20
- HSR100520-20
- HSR100610-20
- HSR100615-20
- HSR100620-20
- HSR100710-20
- HSR100715-20
- HSR100720-20
- HSR100730-20
- HSR100810-20
- HSR100815-20
- HSR100820-20
- HSR100830-20
- HSR100915-20
- HSR100920-20
- HSR100930-20
- HSR101015-20
- HSR101020-20
- HSR101030-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
K. HELIPAQ 18 PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- HEL18020(X)-20
- HEL180204-20
- HEL18030(X)-20
- HEL180308-20
- HEL18040(X)-20
- HEL18041(X)-20
- HEL180410-20
- HEL18050(X)-20
- HEL18051(X)-20
- HEL180515-20
- HEL180520-20
- HEL18061(X)-20
- HEL180620-20
- HEL18071(X)-20
- HEL18072(X)-20
- HEL180730-20
- HEL18081(X)-20
- HEL18082(X)-20
- HEL180830-20
- HEL18091(X)-20
- HEL18092(X)-20
- HEL180930-20
- HEL18102(X)-20
- HEL181030-20
- HEL18112(X)-20
- HEL18122(X)-20
- HEL181230-20
- HEL18142(X)-20
- HEL181430-20
- HEL18162(X)-20
- HEL181630-20
- HEL181830-20
- HEL182030-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
L. ULTIPAQ CERECYTE Microcoils
Lot or serial number
All lots.
Model or catalog number
- CFS 100201-30
- CFS 100202-30
- CFS 100203-30
- CFS 100204-30
- CFS 100206-30
- CFS 100208-30
- CFS 100252-30
- CFS 100254-30
- CFS 100256-30
- CFS 100258-30
- CFS 100302-30
- CFS 100304-30
- CFS 100306-30
- CFS 100308-30
- CFS 100402-30
- CFS 100404-30
- CFS 100406-30
- CFS 100408-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
M. HELIPAQ CERECYTE Microcoils
Lot or serial number
All lots.
Model or catalog number
- CHE 100201-30
- CHE 100202-30
- CHE 100203-30
- CHE 100204-30
- CHE 100206-30
- CHE 100208-30
- CHE 100304-30
- CHE 100306-30
- CHE 100308-30
- CHE 100310-30
- CHE 100404-30
- CHE 100406-30
- CHE 100408-30
- CHE 100410-30
- CHE 100510-30
- CHE 100515-30
- CHE 100520-30
- CHE 100610-30
- CHE 100615-30
- CHE 100620-30
- CHE 100710-30
- CHE 100715-30
- CHE 100720-30
- CHE 100730-30
- CHE 100810-30
- CHE 100815-30
- CHE 100820-30
- CHE 100830-30
- CHE 100915-30
- CHE 100920-30
- CHE 100930-30
- CHE 101015-30
- CHE 101020-30
- CHE 101030-30
- CHE180204-30
- CHE180208-30
- CHE180304-30
- CHE180308-30
- CHE180406-30
- CHE180410-30
- CHE180508-30
- CHE180512-30
- CHE180515-30
- CHE180520-30
- CHE180610-30
- CHE180615-30
- CHE180620-30
- CHE180730-30
- CHE180820-30
- CHE180830-30
- CHE180915-30
- CHE180930-30
- CHE181030-30
- CHE181230-30
- CHE181430-30
- CHE181630-30
- CHE181830-30
- CHE182030-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
N. MICRUSPHERE CERECYTE Microcoils
Lot or serial number
All lots.
Model or catalog number
- CSP 100200-30
- CSP 100300-30
- CSP 100400-30
- CSP 100500-30
- CSP 100600-30
- CSP 100700-30
- CSP 100800-30
- CSP 100900-30
- CSP 101000-30
- CSP100250-30
- CSP100350-30
- CSP180200-30
- CSP180300-30
- CSP180400-30
- CSP180500-30
- CSP180600-30
- CSP180700-30
- CSP180800-30
- CSP180900-30
- CSP181000-30
- CSP181100-30
- CSP181200-30
- CSP181300-30
- CSP181400-30
- CSP181500-30
- CSP181600-30
- CSP181700-30
- CSP181800-30
- CSP181900-30
- CSP182000-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
O. MICRUSPHERE PLATINUM LONGER Microcoils
Lot or serial number
All lots.
Model or catalog number
- SPH100620-20
- SPH100720-20
- SPH100825-20
- SPH100925-20
- SPH101030-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
P. DELTAPLUSH CERECYTE Microcoils
Lot or serial number
All lots.
Model or catalog number
- CPL 100151-30
- CPL 100152-30
- CPL 100153-30
- CPL 100201-30
- CPL 100202-30
- CPL 100203-30
- CPL 100204-30
- CPL 100206-30
- CPL 100252-30
- CPL 100254-30
- CPL 100256-30
- CPL 100304-30
- CPL 100306-30
- CPL 100404-30
- CPL 100406-30
- CPL 100408-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
Q. DELTAPLUSH PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- DPL 100151-20
- DPL 100152-20
- DPL 100153-20
- DPL 100201-20
- DPL 100202-20
- DPL 100203-20
- DPL 100204-20
- DPL 100206-20
- DPL 100252-20
- DPL 100254-20
- DPL 100256-20
- DPL 100304-20
- DPL 100306-20
- DPL 100404-20
- DPL 100406-20
- DPL 100408-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
R. MICRUSPHERE XL 10 PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- SSR 100225-20
- SSR 100253-20
- SSR 100305-20
- SSR 100357-20
- SSR 100408-20
- SSR 100410-20
- SSR 100510-20
- SSR 100514-20
- SSR 100612-20
- SSR 100620-20
- SSR 100714-20
- SSR 100720-20
- SSR 100816-20
- SSR 100825-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
S. MICRUSPHERE XL 18 PLATINUM Microcoils
Lot or serial number
All lots.
Model or catalog number
- SSR 180825-20
- SSR 180927-20
- SSR 181028-20
- SSR 181128-20
- SSR 181230-20
- SSR 181334-20
- SSR 181436-20
- SSR 181540-20
- SSR 181640-20
- SSR 181740-20
- SSR 181840-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
T. ORBIT GALAXY G2 Detachable Coil - CX
Lot or serial number
All lots.
Model or catalog number
- 641CX0201
- 641CX0202
- 641CX0303
- 641CX0304
- 641CX0305
- 641CX0306
- 641CX0307
- 641CX0308
- 641CX0403
- 641CX0404
- 641CX0406
- 641CX0407
- 641CX0408
- 641CX0410
- 641CX0412
- 641CX0415
- 641CX0505
- 641CX0508
- 641CX0510
- 641CX0512
- 641CX0515
- 641CX0609
- 641CX0610
- 641CX0615
- 641CX0620
- 641CX2505
- 641CX2525
- 641CX2535
- 641CX2545
- 641CX3505
- 641CX3509
- 641CX3575
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
U. ORBIT GALAXY G2 Detachable Coils - HX
Lot or serial number
All lots.
Model or catalog number
- 641HX0201
- 641HX0202
- 641HX0203
- 641HX0204
- 641HX0205
- 641HX0206
- 641HX0207
- 641HX0208
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
V. ORBIT GALAXY G2 Detachable Coils - CF
Lot or serial number
All lots.
Model or catalog number
- 641CF0201
- 641CF0202
- 641CF0303
- 641CF0304
- 641CF0305
- 641CF0306
- 641CF0307
- 641CF0308
- 641CF0403
- 641CF0404
- 641CF0406
- 641CF0407
- 641CF0408
- 641CF0410
- 641CF0412
- 641CF0415
- 641CF0505
- 641CF0508
- 641CF0510
- 641CF0512
- 641CF0515
- 641CF0609
- 641CF0610
- 641CF0615
- 641CF0620
- 641CF0713
- 641CF0715
- 641CF0721
- 641CF0725
- 641CF0815
- 641CF0824
- 641CF0825
- 641CF0826
- 641CF0827
- 641CF0828
- 641CF0829
- 641CF0915
- 641CF0925
- 641CF1030
- 641CF1230
- 641CF1430
- 641CF1630
- 641CF1830
- 641CF2030
- 641CF2505
- 641CF2525
- 641CF2535
- 641CF2545
- 641CF3505
- 641CF3509
- 641CF3575
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
W. DELTAMAXX Platinum Microcoils
Lot or serial number
All lots.
Model or catalog number
- DMX180312-20
- DMX180415-20
- DMX180520-20
- DMX180625-20
- DMX180733-20
- DMX180835-20
- DMX180935-20
- DMX181040-20
- DMX181140-20
- DMX181242-20
- DMX181345-20
- DMX181445-20
- DMX181550-20
- DMX181650-20
- DMX181755-20
- DMX181855-20
- DMX181960-20
- DMX182060-20
- DMX182160-20
- DMX182260-20
- DMX182360-20
- DMX182460-20
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
X. DELTAMAXX CERECYTE Microcoils
Lot or serial number
All lots.
Model or catalog number
- CDX180312-30
- CDX180415-30
- CDX180520-30
- CDX180625-30
- CDX180733-30
- CDX180835-30
- CDX180935-30
- CDX181040-30
- CDX181140-30
- CDX181242-30
- CDX181345-30
- CDX181445-30
- CDX181550-30
- CDX181650-30
- CDX181755-30
- CDX181855-30
- CDX181960-30
- CDX182060-30
- CDX182160-30
- CDX182260-30
- CDX182360-30
- CDX182460-30
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND