( Medisp Produtos ).

MEDICAL PRODUCTS
Urgent Field Safety Notice
FSCA 17-06-2014
Retum of the Medical Device to the manufacturer
17-06-2014
Attention: SALZMANN AG
Salzmann MEDICO
Rarschacher Strasse 304
9016 St. Gallen, Switzerland
Tel: +41 71 282 12 12
Fax: +41 71 282 12 10
www.salzmann-qroup.ch
Details on affected devices:
REF
Product name
ME 0048 A Verbandset A
ME0048 A Verbandset A
Qty
Lot
480
480
1403014
1405152
Allthese products have been manufacturer by Medisp Produtos Hospitalares S.A.- Pmtugal.
Description of the problem
The reason for the FSCA is due to a deficiency on the abdominal swab that is inside the dressing
set called "REF ME 0048 A- Verbandset A". The abdominal swab is falling in pmts and small
gauze threads are getting 1oose. In situations like this the potential hazard associated to this failure
is the gauze threads may stay inside the patient during a very sh01t time. This problern is of high
importance for the main intended use of the abdominal swab, therefore the recall of the affected
devices will take place immediately.
Advice on action to be taken by the user
The products have been manufactured by Medisp S.A. and sold to Salzmann AG only.
Medisp S.A. is responsib1e to initiate the retum of the products (recall) and therefore requires the
products to be placed in quarantine. Salzmann AG assures that the products will be in quarantine
at Salzmann' s facilities, this includes alllots that have been distributed to his customers.
Sterisets International B.V.
Ketelmeer 3, 5347 JX OSS
The Netherlands
T +31 {0) 412 667 755
F +31 {0) 412 667 759
E-mail [email protected]
www.sterisets.com
Medisp Produtos Hospitalares, S.A.
Rua do Pali I 88
4560-151 Guilhufe
Penafiel
Portugal
T + 351 255 711 355
MEDICAL PRODUCTS
Transmission of this Field Safety Notice
This notice needs tobe passed on all those who need tobe aware within Salzmann 's organization
and to other organizations on which this action has an impact (Salzmann's customers).
The Swissmedic, Swiss Agency for Therapeutical Products- Medical Devices Division, will be
advised of the FSCA.
Contact manufacturer
Medisp Produtos Hospitalares S.A.
Att.: Mrs. Isabel Nascimento- QAM
Address:
Rua do Paul, 88 4560-151 Guilhufe Penafiel - Portugal
Tel.: 351 255 711 355
Sales office address:
Sterisets International B.V .
Ketelmeer 3
5347 JX Oss
The N etherlands
Tel. : +31 (0) 412 667755
Acknowledgment of receipt
Sterisets B.V./Medisp S.A. requires an acknowledgment ofreceipt ofthi s notice.
Sterisets International B.V./Medisp Produtos Hospitalares, S.A.
Isabel Nascimento- QAM
Sterisets International B.V.
Ket elmeer 3, 53 47 JX OSS
The Net herlands
T +31 (O) 412 667 755
F +31 (O) 412 667 759
E-mail [email protected]
WIVIV.sterisets.com
M edisp Produtos Hospitalares, S.A.
Rua do Paul 88
4560-151 Guilhufe
Penafiel
Portugal
T + 35 1 255 711 355

Download Report