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