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Various Teosyal Products (2014-06-09)
- Starting date:
- June 9, 2014
- Posting date:
- June 18, 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-40073
Recalled Products
A)Teosyal
B)Teosyal Meso
C)Teosyal Kiss
D)Teosyal First Lines
E)Teosyal Ultra Deep
F)Teosyal Ultimate
G)Teosyal Puresense Ultra Deep
H)Teosyal Puresense Kiss
I)Teosyal Puresense Deep Lines
J)Teosyal Puresense Global Action
K)Teosyal Puresense First Lines
L)Teosyal Puresense Redensity I
M) Teosyal Puresense Redensity II
Reason
A foreign incident involving a 48 year old female with a known history of Severe Allergies was injected with Teosyal causing anaphylactic shock (a known and listed contra-indication). While there are no product specific issues, the amending of the IFU’s (to include Anaphylactic Shock in the side effects section) has resulted in the classification of a Recall.
Affected products
A)Teosyal
Lot or serial number
All lots
Model or catalog number
TEOSYAL 27G DEEP LINES (TR)
TEOSYAL 27G DEEP LINES (TSK)
TEOSYAL 27G DEEP LINES SINGLE (TR)
TEOSYAL 27G DEEP LINES SINGLE (TSK)
TEOSYAL 30G GLOBAL ACTION (BD)
TEOSYAL 30G GLOBAL ACTION (TSK)
TEOSYAL 30G GLOBAL ACTION SINGLE (BD)
TEOSYAL 30G GLOBAL ACTION SINGLE (TSK)
TEOSYAL 30G TOUCH UP (O.5ML)(BD)
TEOSYAL 30G TOUCH UP (O.5ML)(TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
B)Teosyal Meso
Lot or serial number
All lots
Model or catalog number
TEOSYAL MESO (BD)
TEOSYAL MESO (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
C)Teosyal Kiss
Lot or serial number
All lots
Model or catalog number
TEOSYAL KISS (TR)
TEOSYAL KISS (TSK)
TEOSYAL KISS SINGLE (TR)
TEOSYAL KISS SINGLE (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
D)Teosyal First Lines
Lot or serial number
All lots
Model or catalog number
TEOSYAL FIRST LINES (BD)
TEOSYAL FIRST LINES (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
E)Teosyal Ultra Deep
Lot or serial number
All lots
Model or catalog number
TEOSYAL ULTRA DEEP (1.2) (TSK)
TEOSYAL ULTRA DEEP (1.2) SINGLE (TR)
TEOSYAL ULTRA DEEP (1.2)(TR)
TEOSYAL ULTRA DEEP (TR)
TEOSYAL ULTRA DEEP (TSK)
TEOSYAL ULTRA DEEP SINGLE (TR)
TEOSYAL ULTRA DEEP SINGLE (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
F)Teosyal Ultimate (TR)
Lot or serial number
All lots
Model or catalog number
TEOSYAL ULTIMATE (TR)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
G)Teosyal Puresense Ultra Deep
Lot or serial number
All lots
Model or catalog number
TEOSYAL PURESENSE ULTRA DEEP (1.2ML) (TR)
TEOSYAL PURESENSE ULTRA DEEP (1.2ML) (TSK)
TEOSYAL PURESENSE ULTRA DEEP (TR)
TEOSYAL PURESENSE ULTRA DEEP (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
H)Teosyal Puresense Kiss
Lot or serial number
All lots
Model or catalog number
TEOSYAL PURESENSE KISS (TR)
TEOSYAL PURESENSE KISS (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
I)Teosyal Puresense Deep Lines
Lot or serial number
All lots
Model or catalog number
TEOSYAL PURESENSE DEEP LINES (TR)
TEOSYAL PURESENSE DEEP LINES (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
J)Teosyal Puresense Global Action
Lot or serial number
All lots
Model or catalog number
TEOSYAL PURESENSE GLOBAL ACTION (TR)
TEOSYAL PURESENSE GLOBAL ACTION (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
K)Teosyal Puresense First Lines
Lot or serial number
All lots
Model or catalog number
TEOSYAL PURESENSE FIRST LINE (TSK)
TEOSYAL PURESENSE FIRST LINES (BD)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
L)Teosyal Puresense Redensity I
Lot or serial number
All lots
Model or catalog number
TEOSYAL PURESENSE REDENSITY I (1ML) (BD)
TEOSYAL PURESENSE REDENSITY I (1ML) (TSK)
TEOSYAL PURESENSE REDENSITY I (32G 1 ML) (TSK)
TEOSYAL PURESENSE REDENSITY I (32G SINGLE ) (TSK)
TEOSYAL PURESENSE REDENSITY I (SINGLE)
TEOSYAL PURESENSE REDENSITY I (SINGLE) (BD)
TEOSYAL PURESENSE REDENSITY I (SINGLE) (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203
M) Teosyal Puresense Redensity II
Lot or serial number
All lots
Model or catalog number
TEOSYAL PURESENSE REDENSITY II
TEOSYAL PURESENSE REDENSITY II (BD)
TEOSYAL PURESENSE REDENSITY II (TSK)
Companies
- Manufacturer
-
TEOXANE SA, LES CHARMILLES, RUE DE LYON, 105, GENEVE, SWITZERLAND 1203
LES CHARMILLES, RUE DE LYON, 105
GENEVE, SWITZERLAND 1203
1203