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Health product recall

Medos International Inline Valves

Starting date:
May 16, 2013
Posting date:
June 17, 2013
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-34211

Recalled products

  1. Inline Valve Only
  2. Inline Valve with Catheter & Accessories
  3. Inline Valve W/ Unitized Catheter & Acc
  4. Inline Valve W/ Unitized Bactiseal Cath
  5. Inline Valve Only W/ Siphonguard Device
  6. Inline Valve, Siphonguard, Catheter & Acc
  7. Inline Valve, Siphonguard, Unitized Cath
  8. Inline Valve, Siphonguard, Unitized Bact

Reason

Codman is initiating a recall for Codman Certas programmable valves because testing shows that in a small percentage of valves the following conditions may exist: the MRI resistance feature may not always operate properly, and, the programming mechanism may not always operate properly.

Affected products

A. Inline Valve Only

Lot or serial number

All lots

Model or catalog number
  • 82-8800
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND

B. Inline Valve with Catheter & Accessories

Lot or serial number

All lots

Model or catalog number
  • 82-8801
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND

C. Inline Valve W/ Unitized Catheter & Acc

Lot or serial number

All lots

Model or catalog number
  • 82-8802
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND

D. Inline Valve W/ Unitized Bactiseal Cath

Lot or serial number

All lots

Model or catalog number
  • 82-8803
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND

E. Inline Valve Only W/ Siphonguard Device

Lot or serial number

All lots

Model or catalog number
  • 82-8804
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND

F. Inline Valve,siphonguard, Catheter & Acc

Lot or serial number

All lots

Model or catalog number
  • 82-8805
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND

G. Inline Valve, Siphonguard, Unitized Cath

Lot or serial number

All lots

Model or catalog number
  • 82-8806
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND

H. Inline Valve, Siphonguard, Unitized Bact

Lot or serial number

All lots

Model or catalog number
  • 82-8807
Companies
Manufacturer
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND