FIELD SAFETY NOTICE
KIMVENT* Closed Suction Systems
EMEA5225
ATTENTION:
Agnetha Helgesson
MEDA AB
TAMRO AB GOTEBORG
IMPORTGATAN 20, PORT 2-4
HISINGS BACKA 0
Sweden
Dear Valued Halyard Health Customer,
What is the reason for this Voluntary Product Advisory Notice?
Halyard Health (formerly known as Kimberly-Clark Health Care) has recently received reports
indicating that the thumb valve of a very small percentage of KIMVENT* Closed Suction Systems
remained partially open after suctioning was completed, even though the valve appeared to be
closed or in the “LOCKED” position. This situation has resulted in a partial air leak from the
ventilator circuit triggering the ventilator alarm and replacement of the closed-suction device.
Therefore, Halyard is notifying all customers who use this device to be aware of this potential issue
and use the steps below to quickly correct the leak. There have been no reports of injuries
associated with this condition to date.
Which Products are impacted?
This Product Advisory Notice applies to the KIMVENT* Closed Suction Systems identified in the list
of potentially affected product codes and lot numbers (reference the ATTACHMENT). These are
organized based on the main product categories. Please note that all potentially affected lots were
shipped between 1st of April and 15th of July 2015.
What is the purpose of this Product Advisory Notice?
This notice is intended to inform all users of the KIMVENT* Closed Suction Systems of this
potential valve leak and to provide instructions that immediately correct the leak.
 In the rare instance that a ventilator begins to alarm after attaching a KIMVENT* ClosedSuction System to the ventilator circuit or after suctioning, the cause might be associated
with the thumb valve of the KIMVENT* System remaining partially open.
 To correct the leak without breaking the circuit, gently pull up on the thumb valve (i.e., in the
Opposite direction than when depressing the thumb valve) and turn to the approximate 90
degree position as shown below (i.e., between the unlocked and locked positions). See
figure.
Halyard Belgium BVBA |Leonardo Da Vincilaan 1 - Building Aramis (4th floor) | 1930 Zaventem | Belgium
T +32 (0)2 711 26 00 | F +32 (0)2 711 26 95 | [email protected]
BTW/TVA/VAT BE 0553 802 001 | Citibank IBAN BE 03570133445584 | SWIFT/BIC CITIBEBX
Ondernemingsnummer/Numéro d’enregistrement/Trade Registration: 0553.802.001 | RPR Brussel/RPM Bruxelles
halyardhealth.nl | halyardhealth.fr | halyardhealth.de | halyardhealth.co.uk
FIELD SAFETY NOTICE
KIMVENT* Closed Suction Systems
EMEA5225



If the leak continues and the ventilator alarm reactivates, replace the KIMVENT* Closed
Suction System.
Please report any occurrence of a valve leak to Halyard Health at the e-mail address
[email protected].
Halyard Health is completing the investigation to prevent recurrence of this issue. If you
require further assistance, please contact your Halyard Health Representative
What should I do in response to this Product Advisory Notice?
1. Please review your distribution records to identify all customers who were shipped any of the
impacted products.
2. Please notify each of your customers, who were shipped or who will be shipped any of the
impacted products.
3. Please notify the competent authority on medical devices of your country, if applicable. Please
note this notification is mandatory for countries of the European Union.
4. Please complete the attached Distributor Response Form and fax it at +32 (0)2 711 26 91 or
e-mail to [email protected] within 5 business days of receipt of this notice.
Thank you for your assistance and we apologize for any inconvenience this may cause.
Sincerely,
Olivier Zarza
Quality and Regulatory Affairs Manager EMEA
On behalf of Thomas Kozma, PhD
Director, Regulatory Affairs
Halyard Belgium BVBA |Leonardo Da Vincilaan 1 - Building Aramis (4th floor) | 1930 Zaventem | Belgium
T +32 (0)2 711 26 00 | F +32 (0)2 711 26 95 | [email protected]
BTW/TVA/VAT BE 0553 802 001 | Citibank IBAN BE 03570133445584 | SWIFT/BIC CITIBEBX
Ondernemingsnummer/Numéro d’enregistrement/Trade Registration: 0553.802.001 | RPR Brussel/RPM Bruxelles
halyardhealth.nl | halyardhealth.fr | halyardhealth.de | halyardhealth.co.uk
FIELD SAFETY NOTICE
KIMVENT* Closed Suction Systems
EMEA5225
ATTACHMENT
Lists of Potentially Affected KimVent* System Codes
Catalog/product
code
Description
Closed Suction System for Neonates / Pediatrics, 12 F, Y-Adapter
1912-5
195-5
197-5
198-5
Closed Suction System for Neonates / Pediatrics, 5 F, Y-Adapter
Closed Suction System for Neonates / Pediatrics, 7 F, Y-Adapter
Lot Code
M5096T514
M5110T408
M5076T402
M5096T517
M5082T505
Closed Suction System for Neonates / Pediatrics, 8 F, Y-Adapter
M5082T502
Closed Suction System for Adults, 12 F, T-Piece
215125-5
22103-5
M5103T601
Closed Suction System for Adults, 14 F, DSE
M5085T604
22716-5
Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE
240165-5
KimVent* Multi-Access Port Replacement Catheter for Adults,
Endotracheal, 16 F
M5089T307
Halyard Belgium BVBA |Leonardo Da Vincilaan 1 - Building Aramis (4th floor) | 1930 Zaventem | Belgium
T +32 (0)2 711 26 00 | F +32 (0)2 711 26 95 | [email protected]
BTW/TVA/VAT BE 0553 802 001 | Citibank IBAN BE 03570133445584 | SWIFT/BIC CITIBEBX
Ondernemingsnummer/Numéro d’enregistrement/Trade Registration: 0553.802.001 | RPR Brussel/RPM Bruxelles
halyardhealth.nl | halyardhealth.fr | halyardhealth.de | halyardhealth.co.uk
M5089T807
FIELD SAFETY NOTICE
KIMVENT* Closed Suction Systems
EMEA5225
Distributor Response Form
Please FAX a copy of this form to +32 (0)2 711 26 91, or send it via email at
[email protected], within 5 business days of receipt of this notice.
Facility:
MEDA AB TAMRO AB GOTEBORG
IMPORTGATAN 20, PORT 2-4
HISINGS BACKA 0
Sweden
Our records indicate that you may have received certain impacted products identified in the chart below
Catalog/product
code
1912-5
Description
Closed Suction System for Neonates / Pediatrics, 12 F, Y-Adapter
195-5
Closed Suction System for Neonates / Pediatrics, 5 F, Y-Adapter
M5110T408
M5076T402
Closed Suction System for Neonates / Pediatrics, 7 F, Y-Adapter
M5096T517
197-5
Lot Code
M5096T514
M5082T505
198-5
Closed Suction System for Neonates / Pediatrics, 8 F, Y-Adapter
M5082T502
Closed Suction System for Adults, 12 F, T-Piece
215125-5
22103-5
M5103T601
Closed Suction System for Adults, 14 F, DSE
M5085T604
22716-5
Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE
240165-5
KimVent* Multi-Access Port Replacement Catheter for Adults,
Endotracheal, 16 F
M5089T307
M5089T807
[ ] I certify that this facility has read and understood the information provided in the FSN
[ ] I certify that this facility has notified the customers, who were shipped any of the impacted products
and will notify the customers that will receive the impacted products
I certify that the competent authority for medical devices of my country has been informed of this field safety
notice:
[ ] Yes
[ ] N/A
_____________________________________________
(Signature)
(Date)
_____________________________________________
(Name – print)
_____________________________________________
(Title – print)
Halyard Belgium BVBA |Leonardo Da Vincilaan 1 - Building Aramis (4th floor) | 1930 Zaventem | Belgium
T +32 (0)2 711 26 00 | F +32 (0)2 711 26 95 | [email protected]
BTW/TVA/VAT BE 0553 802 001 | Citibank IBAN BE 03570133445584 | SWIFT/BIC CITIBEBX
Ondernemingsnummer/Numéro d’enregistrement/Trade Registration: 0553.802.001 | RPR Brussel/RPM Bruxelles
halyardhealth.nl | halyardhealth.fr | halyardhealth.de | halyardhealth.co.uk
FIELD SAFETY NOTICE
KIMVENT* Closed Suction Systems
EMEA5225
Halyard Belgium BVBA |Leonardo Da Vincilaan 1 - Building Aramis (4th floor) | 1930 Zaventem | Belgium
T +32 (0)2 711 26 00 | F +32 (0)2 711 26 95 | [email protected]
BTW/TVA/VAT BE 0553 802 001 | Citibank IBAN BE 03570133445584 | SWIFT/BIC CITIBEBX
Ondernemingsnummer/Numéro d’enregistrement/Trade Registration: 0553.802.001 | RPR Brussel/RPM Bruxelles
halyardhealth.nl | halyardhealth.fr | halyardhealth.de | halyardhealth.co.uk