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Health product recall

Angiojet Ultra Thrombectomy System (2014-06-12)

Starting date:
June 12, 2014
Posting date:
July 15, 2014
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-40553

Recalled products

  1. Angiojet Ultra Thrombectomy System - XMI Tthrombec
  2. Angiojet Ultra Thrombectomy System - AVX Thrombec
  3. Angiojet Ultra Thrombectomy System - Ppiroflex TH
  4. Angiojet Ultra Thrombectomy System - Solent Omni
  5. Angiojet Ultra Thrombectomy System - Solent Proxi

Reason

It has been determined that the expiration date indicated on the Angiojet  Ultra Thrombectomy System is beyond the original shelf life date. Therefore, although there is sufficient data that supports the safe use of the products throughout their currently labeled expiration dates, the product is request to be returned.

Affected products

A. Angiojet Ultra Thrombectomy System - XMI Tthrombec

Lot or serial number
  • 162621
Model or catalog number
  • 105041
Companies
Manufacturer
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES

B. Angiojet Ultra Thrombectomy System - AVX Thrombec

Lot or serial number
  • 161660
  • 162619
Model or catalog number
  • 105039
Companies
Manufacturer
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES

C. Angiojet Ultra Thrombectomy System - Ppiroflex TH

Lot or serial number
  • 162625
Model or catalog number
  • 106553
Companies
Manufacturer
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES

D. Angiojet Ultra Thrombectomy System - Solent Omni

Lot or serial number
  • 163334
Model or catalog number
  • 109681-TAB
Companies
Manufacturer
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES

E. Angiojet Ultra Thrombectomy System - Solent Proxi

Lot or serial number
  • 162648
  • 162725
Model or catalog number
  • 109676-TAB
Companies
Manufacturer
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES

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