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U.S. Department of Health and Human Services

Class 1 Device Recall Neptune Waste Management System

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 Class 1 Recall
Neptune Waste Management System
see related information
Date Posted August 15, 2012
Recall Status1 Open
Recall Number Z-2063-2012
Recall Event ID 61747
Premarket Notification
510(K) Number
K012991 
Product Classification Apparatus, Exhaust, Surgical - Product Code FYD
Product Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Code Information Part : 0700-007-000, all lot numbers IFU Part number 0700-007-720
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage, Michigan 49002-9704
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Angela Ragainis
269-323-7700
Manufacturer Reason
for Recall
Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high fl
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Customers must confirm with Stryker via business reply form that they have completed these actions. Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 2 Bronze will receive a follow up mailing containing warning labels for the device and instructions detailing how to apply them. Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze without any further actions. On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992). As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices. At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Nept.
Quantity in Commerce 1075
Distribution Worldwide Distribution -- USA (nationwide) and country of: Canada. .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FYD and Original Applicant = STRYKER INSTRUMENTS
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