Health product recall

Pressure Slave Cable (2018-05-15)

Starting date:
May 15, 2018
Posting date:
June 6, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66978

Affected products

Pressure Slave Cable

Reason

Pressure Slave Cable part no. 650404-004, model number 70anm, contains a capacitor part no. 851525026 that is not RoHS compliant. The European Union Directive 2011/65/EU on the restriction of hazardous substances (RoHS II) restricts the use of specific hazardous materials found in electrical and electronic products. The capacitor inside of slave cable contains 40% lead.

Affected products

Pressure Slave Cable

Lot or serial number

S1506036

Model or catalog number

70ANM5

Companies
Manufacturer

Edwards Lifesciences LLC

1 Edwards Way

Irvine

92614

UNITED STATES