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Variuos Instruments from Gelweave Vascular Prosthesis (2014-07-08)
- Starting date:
- July 8, 2014
- Posting date:
- August 1, 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-40813
Recalled Products.
A) Gelweave, Straight
B) Gelweave, Siena Collared Ante-Flo
C) Gelweave,Siena Collared 4 Branch Plexus
D) Gelweave, Bifurcate
E) Gelweave, Ante-Flo
F) Gelweave, Plexus 3-Branch
G) Gelweave, Valsalva
H) Gelweave, Ante-Flo with Collar
I) Gelweave, Arch Graft
J) Gelweave, Trifurcate
Reason
Vascutek is providing important user information regarding Gelweave Vascular Prosthesis. Currently Vascutek provides a high temperature cautery with each Gelweave vascular graft. Vascutek have decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the graft.
Affected products
A) Gelweave, Straight
Lot or serial number
All lots
Model or catalog number
731030
731032
731034
731218
731220
731222
731224
731226
731228
731506
731508
731510
731512
731514
731516
732030
732032
732034
732038
732518
732520
732522
732524
732526
732528
733006
733008
733010
733012
733014
733016
733034
733036
734030
734032
734036
734038
735018
735020
735022
735022ST
735024
735024ST
735026
735026ST
735028
735028ST
735030
735030ST
735032
735032ST
735034
735034ST
736006
736008
736010
736014
736016
736022
736024
736026
736028
736030
736032
736034
736038
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
B) Gelweave, Siena Collared Ante-Flo
Lot or serial number
All lots
Model or catalog number
735022/8RM
735024/8RM
735026/8RM
735028/8RM
735030/8RM
735032/8RM
835034/8RM
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
C) Gelweave,Siena Collared 4 Branch Plexus
Lot or serial number
All lots
Model or catalog number
73241088/8RM
73261088/8RM
73281088/8RM
73301088/8RM
73321088/10RM
73321088/8RM
73341088/10RM
73341088/8RM
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
D) Gelweave, Bifurcate
Lot or serial number
All lots
Model or catalog number
731206
731407
731608
731809
732010
732211
732412
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
E) Gelweave, Ante-Flo
Lot or serial number
All lots
Model or catalog number
732026/8
732028/8
732030/8
732032/8
732034/8
734020/8
734022/8
734024/10
734024/8
734026/10
734026/8
734028/10
734028/8
734030/10
734030/8
734032/10
734032/8
734034/10
734034/8
735022/8S
735022ST/8A
735024/8S
735024ST/8A
735026/8S
735026ST/8A
735028/8S
735028ST/8A
735030/8S
735030ST/8A
735032/8S
735032ST/8A
735034ST/8A
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
F) Gelweave, Plexus 3-Branch
Lot or serial number
All lots
Model or catalog number
731206/7
731407/7
732010108/8S4
732012/10X2
732012/8X2
732014/10X2
732014/8X2
732210108/8S4
73221088/8
732410108/8S4
73241088/8
732610108/8S4
73261088/8
73261410128ST
7326141012ST
732810108/8S4
73281088
73281088/10
73281088/8
73281410128ST
7328141012ST
733010108/8S4
73301088
73301088/10
73301088/8
73321088
73321088/10
73321088/8
73341088
73341088/8
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
G) Gelweave, Valsalva
Lot or serial number
All lots
Model or catalog number
730024ADP
730026ADP
730028ADP
730030ADP
730032ADP
730034ADP
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
H) Gelweave, Ante-Flo with Collar
Lot or serial number
All lots
Model or catalog number
73201088/10ET
73201088/8ET
73221088/10ET
73221088/8ET
73241088/10ET
73241088/8ET
73261088/10ET
73261088/8ET
73281088/10ET
73281088/8ET
73301088/10ET
73301088/8ET
73321088/10ET
73321088/8ET
73341088/10ET
73341088/8ET
734520/10ET
734520/8ET
734522/10ET
734522/8ET
734524/10ET
734524/8ET
734526/10ET
734526/8ET
734528/10ET
734528/8ET
734530/10ET
734530/8ET
734532/10ET
734532/8ET
734534/10ET
734534/8ET
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
I) Gelweave, Arch Graft
Lot or serial number
All lots
Model or catalog number
732028CX4
732030CX4
732032CX4
732212/10/8ARM
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
J) Gelweave, Trifurcate
Lot or serial number
All lots
Model or catalog number
731407/10/10RM
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM