Stryker

NEPTUNE Waste Management System

NEPTUNE 2 Docker Urgent Field Safety Notice Aug 2015

Recall

Fluid coupling sleeve

4 Pages

Stryker House, Hambridge Road Newbury, Berkshire RG14 5AW t: +44(0)1635 262400 f: +44(0)1635 580300 www... ryker... UK URGENT Field Safety Notice: RA 2015-092 25th August 2015 Description: Neptune® 2 Docker (STRYKER NEPTUNE® 2 WASTE MANAGEMENT SYSTEM) Product Code: 0702-014-000 Lot Number: See list on page 3 Dear Neptune 2 Customer, Stryker Instruments has initiated a Product Field Action for the devices identified above... he purpose of this letter is to list the hazards potentially associated with the Product Field Action... Issue The Fluid Coupling Sleeve, a component within the Neptune® Waste Management System Docker has the potential to be out of specification... ote: Not all Dockers listed will be out of specification, only those having the recalled component with certain lot codes... Stryker service technician will inspect all Dockers possibly affected and repair if necessary... roduct Description The Stryker Docking Station (Docker) is a component of the Neptune® 2 Waste Management System... he Stryker Rover, another component of the system, is a mobile unit used to suction and collect fluid waste and surgical smoke from a surgical site in an operating room... fter collection, the Rover is mated to the Docker and the emptying of fluid waste and cleaning of the canisters occurs automatically... isk to Health If a Docker contains a nonconforming Fluid Coupling Sleeve component, the Fluid Coupling Sleeve has a small potential to cut or dislodge the Rover fluid coupling seal during docking... ossible damage to the Rover coupling seal would cause an immediate failure... ossible leakage from the Rover may result in a wet floor, which if unrecognised, may cause user to slip, resulting in soft tissue or bone injury to user... Stryker UK & UK/Ireland/South Africa are the trading names for Stryker UK Limited Registered Office: Stryker House, Hambridge Road, Newbury, Berkshire RG14 5AW Registered in England No... 669454 VAT Reg... o... B 787 438 685 RS11877 Actions Required 1... mmediately check your internal inventory 2... irculate this Field Safety Notice internally to all interested / affected parties... aintain awareness of this notice internally until all required actions have been completed within your facility... nform Stryker if any of the subject devices have been distributed to other organisations... ) Please provide contact details so that Stryker can inform the recipients appropriately... omplete the attached customer response form and return to Mark Fielding by fax (01635 262 464) or by e-mail ( @stryker... m)... ) Please complete this form even if you do not have any affected product... his will preclude the need for Stryker to send any reminder notice... pon receipt of a completed response form, a Stryker Representative will contact your facility to schedule an engineer to inspect your Docker... f necessary the Docker will be repaired... lease inform Stryker of any adverse events concerning the use of the subject devices... omply with any local laws or regulations concerning the notification of adverse events to your National Competent Authority... On behalf of Stryker we thank you sincerely for your help and support in completing this action and regret any inconvenience that may be caused... e would like to reassure you that Stryker is committed to ensuring that only conforming devices, meeting our high internal quality standards, remain on the market... f you have any further enquiries, please do not hesitate to contact the undersigned... ours faithfully, Quality Assurance and Regulatory Affairs 2
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File Name: neptune_2_docker_urgent_field_safety_notice_aug_201.pdf
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