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Health product recall

CUI Tissue Expanders (2015-06-22)

Starting date:
June 22, 2015
Posting date:
July 8, 2015
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-54116

Recalled Product

  1. CUI TISSUE EXPANDER-VERSAFIL
  2. CUI TISSUE EXPANDER-STANDARD

Reason

ALLERGAN is recalling specific lots of Natrelle CUI Tissue Expanders because product was shipped beyond its 5-year shelf life.

Affected products

A.CUI TISSUE EXPANDER-VERSAFIL

Lot or serial number

09H024-OEM/SN VF4562
4G024-OEM/SN VE5903

Model or catalog number

SRV-1605

Companies
Manufacturer
Allergan, Inc.
5540 Ekwill Street
Santa Barabara
California
UNITED STATES

B.CUI TISSUE EXPANDER-STANDARD
 

Lot or serial number

3F147-OEM/SN VE3904
4A072-OEM/SN VE4547
6F158-OEM/SN VE9116
7L043-OEM/SN VF1324
7L085-OEM/SN VF1430

Model or catalog number

SFS-300
SFS-700
SOE-4528

Companies
Manufacturer
Allergan, Inc.
5540 Ekwill Street
Santa Barabara
California
UNITED STATES