Health product recall

Dual Collapser (2020-08-29)

Starting date:
August 29, 2020
Posting date:
September 18, 2020
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-73917



Last updated:
2020-09-18

Affected Products

A. Dual Collapser

B. Dual Collapser

Reason

The Dual Collapser size small/medium (S/M) may present misaligned collapser segment arrays. This may result in the inability to collapse the inflow ring of perceval(s) valve sizes S and M.

Affected products

A. Dual Collapser

Lot or serial number
  • 2001300339
  • 2002130159
  • 2002200196
Model or catalog number

ICV1349

Companies
Manufacturer

Sorin Group Italia S.R.L.

Via Crescentino, SN,

Saluggia, Vercelli,

13040

ITALY


B. Dual Collapser

Lot or serial number
  • 2001300341
  • 2002060224
  • 2002130160
  • 2002130161
  • 2002130162
  • 2002200198
  • 2002200199
Model or catalog number

ICV1350

Companies
Manufacturer

Sorin Group Italia S.R.L.

Via Crescentino, SN,

Saluggia, Vercelli,

13040

ITALY