Urgent Field Safety Notice
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- Marylou Martin
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1 Urgent Field Safety Notice Urgent Field Safety Notice concerning CombiSets containing Medtronic Covidien Devon TM Light Glove according to attachment 1. May 12, 2015 Sender: PAUL HARTMANN AG Paul-Hartmann-Str Heidenheim Recipient: affiliate / authorized distributor Affected product: Complete list as per attachment 1 Description of the problem and Product Advisory Notice: We have been informed by our supplier Medtronic regarding their Covidien Devon Light Gloves about an Urgent Field Safety Notice as per attachment 2 (Urgent Field Safety Notice dated ). These Devon Light Gloves are used as a component in HARTMANN CombiSets. Medtronic informed that affected lots of Covidien Devon Light Gloves could contain splits or holes. Should the user be unaware that the Light Glove is torn/split, a transfer of microorganisms from the light handle into the patient wound is possible when the clinician touches the handle and then onto the sterile field. Surgical site infections can cause morbidity, prolonged hospitalization, and death. They pointed out, that no adverse events have been reported. So far, we have also not received any reports of incidents related to this issue in connection with our CombiSets. The Medtronic Light Gloves can be easily recognized among the kit components by their green colour and shape. The Devon Light Glove must be discarded. All the other CombiSet components are not affected and can be used. Advise on actions: Please take note and confirm receipt of this Urgent Field Safety Notice. We kindly ask you to complete and return attachment 3 Response form 1 Affiliate Reception & Transmission until Friday Users are advised to affix a copy of this advisory notice to the affected products to insure that the information communicated in this notice is followed. During preparation of the surgical procedure at the customer the affected component Devon Light Gloves should be identified and discarded. All the other set components are not affected and can be used. On demand we provide sterile packaged light gloves from an alternative supplier which you can offer to your customers as replacement. Customers should be advised to contact for their order their usual HARTMANN sales representative. For confirmation of closure please complete and return attachment 4 Response form 2 Closure until Friday Your contact for further information is Dr. Werner Casper, telephone: (+49)
2 Transmission of this Urgent Field Safety Notice: This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected products have been transferred to. Therefore please take adequate measures. A template for a customer letter is enclosed. Customers are requested to confirm receipt of the Urgent Field Safety Notice to the local HARTMANN affiliates / authorised distributor. We do require your written confirmation of implementation and closing of the actions above. This Urgent Field Safety Notice has been submitted to the Competent Authorities of the concerned countries within the European Economic Area (EEA). Heidenheim, May, PAUL HARTMANN AG Michael Brauner Dr. Werner Casper Attachments: 1. List of affected HARTMANN products 2. Urgent Field Safety Notice Medtronic Covidien 3. Response form 1 Affiliate Reception & Transmission Response form 2 Affiliate Closure
3 Anlage 1 / attachment 1: Artikelliste / product list DE REF (Artikelnr.) / REF (articel no.) Handelsname / Trade name LOT Nr. / Batch no CombiSet Bandscheiben-Set CombiSet Wirbelsäulenset CombiSet Gyn-Universal-Set I CombiSet Laparoskopie-Set CombiSet Hüft-Combiset CombiSet Uni-Set CombiSet Schrittmacher-Set CombiSet Sectio-Notfallset CombiSet Sectio-Notfallset CombiSet Standardset für große OP CombiSet Schlitztuch-Set CombiSet Extremitäten-Set CombiSet Standardset für kleine OP CombiSet Steinschnitt-Set für große OP CombiSet Schulterarthroskopie-Set CombiSet Hüft-/Schulter-Set FDS CombiSet Ventil-Set CombiSet CombiSet Sectio-Set
4 CombiSet Spongiosa Set CombiSet Plastisches Chirurgie Set CombiSet Sectio-Set CombiSet Sectio-Set CombiSet Bohrloch-Set CombiSet Rektum Set Frdst CombiSet Universal Set CombiSet TEP-Set CombiSet Bauch-Set CombiSet Bauch-Set CombiSet Extremitäten Set Frdst. CombiSet Schrittmacher-Port Set CombiSet Kreuzband-Set CombiSet SM-Port Set CombiSet OSG Fraktur-Set CombiSet OSG Fraktur-Set CombiSet Hand-Set CombiSet Knie-Arthroskopie-Set, FDS CombiSet Knie-TEP-Set FDS CombiSet Trauma-Set klein CombiSet ME - Set CombiSet Knie-TEP-Set FDS CombiSet Universal-Set Rückenlage MOD CombiSet Hand-Fuß-Set MOD ambulant
5 CombiSet Hand Set CombiSet PFNA+ DHS-Set CombiSet Sectio-Set CombiSet Vaginal-Set CombiSet Varizen-Set Hs. MOD CombiSet Uni-Set CombiSet Uni-Set CombiSet Varizen-Set Bretten CombiSet Sectio-Set CombiSet Spezial-Varizenset CombiSet Laparoskopie-Set CombiSet Varizen-Set Bretten CombiSet Basis-Hand-Tray "neu" CombiSet Basis-Hand-Tray "neu" CombiSet Universal-Set CombiSet Universal-Set CombiSet Basis-Set Diako, Augsburg CombiSet Abdominal-Set Bretten
6 CombiSet Gyn-Abdominal-Set CombiSet LSK-Set Bretten CombiSet Schlitztuch-Set FDS CombiSet LSK-Set Bretten CombiSet LSK-Set Bretten CombiSet Vertikaltuch-Set CombiSet Intertan /Gammanagel->Set CombiSet Hüft-TEP-Set CombiSet Knie-TEP-Set CombiSet Endoskopische Sigmaresektion CombiSet Endoskopische Sigmaresektion CombiSet ZMK-Set klein "neu" CombiSet ZMK-Set klein CombiSet Mamma OP Set CombiSet LAVH -Set Plus MIC-KL. CombiSet Schrittmacher-Set CombiSet Hand-Fuss-Set Diako CombiSet Hüft Set Bad Säckingen CombiSet Sectio- Set CombiSet Pelviskopie Set CombiSet Pelviskopie Set CombiSet vaginale HE Set
7 CombiSet Nieren Prostata Set CombiSet Schulter-Arthroskopie-Set DRK CombiSet Schulter-Arthroskopie-Set DR CombiSet Schulter-Arthroskopie-Set DR CombiSet Ambulanz Basis -Set groß CombiSet Schrittmacher-Port Set CombiSet Schrittmacher-Port Set CombiSet Knie-TEP-Set CombiSet Hand-Set CombiSet MKG-Set oral CombiSet MKG-Set oral CombiSet Mamma-Set CombiSet Mamma-Set CombiSet Knie-TEP-Set CombiSet vaginale HE Set CombiSet Laparotomie Set CombiSet Lap-Set klein
8 CombiSet Knie-TEP-Set CombiSet Knie-TEP-Set CombiSet Hüft-Set CombiSet Hüft-Set CombiSet Hüft-Set CombiSet Hüft-Set CombiSet Hüft-Set CombiSet Wirbelsäulen-Set CombiSet Wirbelsäulen-Set CombiSet Ambulanz Zirkumzisions-Set CombiSet Basis-Schlitztuch Set klein CombiSet Wirbelsäulen-Set CombiSet Schlitztuch Set klein CombiSet Laparoskopie-Set klein CombiSet Intraport ambulant Set CombiSet Intraport-Set CombiSet Hals-Set CombiSet Hals-Set CombiSet Hals-Set CombiSet Nasen-Ohren-Set CombiSet Nasen-Ohren-Set CombiSet Nasen-Ohren-Set CombiSet Nasen-Ohren-Set CombiSet Da Vinci-Uro-Set CombiSet Thorakotomie-Set CombiSet Thorakotomie-Set
9 CombiSet Thorakotomie-Set CombiSet Thorakotomie-Set CombiSet Struma-Set CombiSet Carotis-Set CombiSet Carotis-Set CombiSet Carotis-Set CombiSet Laparoskopie-Set groß CombiSet Laparoskopie-Set groß CombiSet Abdominal-Gyn-Set CombiSet Vaginal-Set CombiSet Vaginal-Set CombiSet BAA- Set CombiSet Kreuzband-Set CombiSet Fem-Pop-Set CombiSet Struma-Set (Komplett-Set) CombiSet Nephrektomie-Set CombiSet BAA-Komplett-Set CPT CombiSet Kreuzband-Set CombiSet Zystektomie- Set CombiSet Fem-Pop-Set CombiSet Basis-Schlitztuch-Set groß CombiSet Steinschnitt-Set CombiSet Lap-Gyn-Set CombiSet Lap-Gyn-Set CombiSet Hüft- und Knie-Set CombiSet Hüft- und Knie-Set CombiSet Kopf- Set CombiSet Vertikaltuch Set CombiSet Hand - Fuß Set Frdst CombiSet Sectio Set Standard
10 CombiSet Hand - Fuß Set Frdst CombiSet Universal Set Super Frdst CombiSet Varizen-Set CombiSet ASK-Set CombiSet ASK-Set CombiSet MIC-Set CombiSet MIC-Set CombiSet TEP-Set CombiSet Varizen-Set CombiSet Universal Set Super Frdst. CombiSet Hand Chirurgie Set CombiSet Vaginal- Set CombiSet Sectio Set Standard CombiSet MIC-Set CombiSet Struma-Set CombiSet Schulter-ASK-Set CombiSet ASK - Knie CombiSet Trauma-Set groß CombiSet Makrokopf-Set CombiSet Trauma-Set groß CombiSet PFNA+ DHS-Set CombiSet MIC-Universal-Set CombiSet MIC-Universal-Set CombiSet MIC-Universal-Set CombiSet Diskus-Set CombiSet Lid-OP-Set CombiSet MIC-Universal-Set CombiSet Uni-Set CombiSet Uni-Set CombiSet Laparotomie Set
11 CombiSet Hand-Fuß-Set MOD CombiSet Hand-Fuß-Set MOD ambulant CombiSet Laparoskopie-Set CombiSet Laparoskopie-Set CombiSet Hals-Set CombiSet Da Vinci-Uro-Set CombiSet Laparoskopie-Set groß CombiSet Schlitztuch-Set groß CombiSet Steinschnitt-Set CombiSet Steinschnitt-Set CombiSet Lap-Gyn-Set CombiSet Vertikaltuch Set CombiSet MIC-Hernien-Set CombiSet Schädel-Set CombiSet Schädel-Set CombiSet Schädel-Set CombiSet BSV-Set CombiSet Schulter-Ask-Set CombiSet Hüft-TEP-Set CombiSet Lap-Set klein CombiSet Hand-Fuß-Set Standard CombiSet Hand-Fuß-Set extra CombiSet Lid-OP-Set
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