HAZARD NOTICE By arrangement with the Scottish Executive Health Department

Transcription

1 HAZARD NOTICE By arrangement with the Scottish Executive Health Department FALCON MILLER SINGLE USE PAEDIATRIC LARYNGOSCOPE BLADES SUPPLIED BY DRAEGER MEDICAL: PRODUCT RECALL HAZ(SC)07/12 23 AUG 2007 Page 1 of 6 Pages SUMMARY Falcon Miller single use paediatric laryngoscope blades may fail to adequately illuminate the airway or over heat. The supplier, Draeger Medical, has issued a product recall on certain sizes and lots. BACKGROUND 1. Draeger Medical supplies laryngoscope blades manufactured by Falcon Surgical Co. (PVT) Ltd. As directed by the manufacturer, Draeger Medical has issued a product recall on certain sizes and lots for Falcon Miller single use paediatric laryngoscope blades. 2. Falcon has advised that implicated blades may provide poor airway illumination and/or become heated. The fault has been identified as a manufacturing problem relating to the bulb. 3. Draeger Medical issued the manufacturer s product recall notice on 13 August 2007 (see Annexe). Identification criteria for implicated blades are given in Table 1 below. Please note that the blades are supplied in boxes that may be labeled with either the Draeger or Falcon part numbers and the lot numbers are stamped into the flat base of the blade. Falcon Part Number MIL320 MIL310 MIL301 Draeger Part Number MP01241 MP01239 MP01242 Blade Type/Size Miller/No. 00 Miller/No. 0 Miller/No. 01 Lot Numbers ACTION L H L K L A L G L C L F L E Table 1 L H L L L F L F L E L M L G L D L B 4. This notice should be brought to the attention of all appropriate managers, staff and users. Suggested Distribution Accident & Emergency Ambulance Services Anaesthetics Day Surgery Dental Hospitals Health & Safety Hospices Intensive Therapy Units Maternity Medical Medical Physics Neonatal Nursing O.D.A.s / O.D.P.s Operating Departments Paediatrics Resuscitation Teams Risk Management Special Care Baby Units Stores Supplies/Procurement Surgical Wards SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT iric@shs.csa.scot.nhs.uk FAX: WEBSITE: HAZ\HAZ0712.DOC

2 HAZARD NOTICE By arrangement with the Scottish Executive Health Department FALCON MILLER SINGLE USE PAEDIATRIC LARYNGOSCOPE BLADES SUPPLIED BY DRAEGER MEDICAL: PRODUCT RECALL HAZ(SC)07/12 23 AUG 2007 Page 2 of 6 Pages 5. All implicated Falcon Miller single use paediatric laryngoscope blades (see Table 1) should be identified, removed from use and placed in quarantine 6. Draeger Medical should be contacted (see Enquiries) to arrange for the free of charge replacement of implicated blades. If Draeger do not require the return of implicated products, they should be appropriately disposed of once replacements are received. 7. If there is no alternative but to use an implicated blade, the beam focus test should be carried out prior to use in accordance with the instructions issued by Falcon (see Annexe). 8. Adverse incidents involving Falcon Miller single use paediatric laryngoscope blades should be reported to Draeger Medical and Scottish Healthcare Supplies. ENQUIRIES Enquiries to the manufacturer should be addressed to: Mr Doug Sims Draeger Medical UK Ltd. The Willows Mark Road Hemel Hempstead HP2 7BW Tel: Fax: doug.sims@draeger.com SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT iric@shs.csa.scot.nhs.uk FAX: WEBSITE: HAZ\HAZ0712.DOC

3 ANNEXE 23 AUG 2007 Page 3 of 6 Pages To all Risk Managers August 2007 Dear Risk Manager Re: Important Safety Notice - Falcon Miller blades Please find enclosed an Important manufacturer Recall Notice in respect of the Falcon Miller Blades sizes 00, 0, 01. We would be grateful if you could circulate this information to the relevant Clinical Users within your Trust Group. In addition to this we would be grateful if you could include any other department you feel may benefit from this notice. Clinical users who identify stock affected by the manufacturers recall notice should be advised to contact Ms: Pauline Read at Draeger Medical UK Limited by telephoning or by pauline.read@draeger.com for further information or assistance. To enable us to monitor the effectiveness of the circulation of the information, we request you confirm receipt of this letter and enclosed customer information by returning the form titled 'Confirmation of Receipt'. Please confirm receipt by Draeger remain dedicated to the provision of quality medical devices and a quality customer service, if however you have any further questions or queries regarding our corrective action, please do not hesitate to contact our Quality Department on or to ukhealth@draeqer.co.uk Yours sincerely Natalie Holliday Quality Department Draeger Medical UK Ltd

4 ANNEXE (CONT.) 23 AUG 2007 Page 4 of 6 Pages Draeger Medical UK Ltd Important Safety Information Laryngoscope Falcon miller blades Confirmation of Receipt. As EBME Manager/Risk Manager of I would like to confirm I have read and understood the important safety information concerning Laryngoscope Falcon miller blades. Signature: Name: Date: Please return this form by post, , or fax: Address: Quality Department Draeger Medical UK Ltd The Willows Mark Road Hemel Hempstead Hertfordshire HP2 7BW ukhealth@draeger.com Fax:

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