Stryker Instruments, Neptune Rover Waste Management Systems
Recall Class: Class I
Date Recall Initiated: June 8, 2012
Product: Neptune Waste Management System
|Device Name||Lot Number||Part Number|
|Neptune 2 Rover Ultra (120V)||All serialized devices||0702-001-000|
|Neptune 2 Rover Ultra (230V)||All serialized devices||0702-002-000|
|Neptune 1 Gold Rover (120V)||All serialized devices||0700-001-000|
|Neptune 1 Gold Rover International (230V)||All serialized devices||0700-002-000|
|Neptune 1 Silver Rover (120V)||All serialized devices||0700-003-000|
|Neptune 1 Bronze Rover||All serialized devices||0700-007-000|
These products were manufactured from February 2001 through April 6, 2012 and distributed from March 26, 2001 through April 6, 2012.
Use: The Neptune Waste Management System is intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities. The Neptune 2 Ultra can also remove smoke generated at surgical sites by electrocautery or laser devices. Both systems consist of a mobile rover unit that can be relocated to a waste disposal area so the waste collection canisters can be emptied through the device’s docking station.
4100 East Milham Ave
Portage, Michigan 49002-9704
Reason for Recall:
Stryker Instruments has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2 device, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube postoperatively resulting in a fatality. The current Instructions for Use (IFU) for models in the Neptune Waste Management System do not specifically warn against connecting the device in situations where passive drainage is needed. FDA also advised Stryker that both the Neptune Silver and Neptune 2 devices require, but do not currently have, a 510(k) clearance, and therefore FDA is unable to determine whether these devices are as safe and effective as their legally marketed predicate, Neptune 1 (Gold) Waste Management System (510(k) K012991).
Public Contact: Customers with questions about the recall may contact the Recall Coordinator Monday through Friday, 8 a.m. to 5 p.m. (EST) at 1-289-389-4354 or by email at email@example.com.
FDA District: Detroit
FDA Comments: On June 5, 2012 Stryker began contacting US customers through certified mail and international customers through E-mail. Stryker sent its customers the Urgent Medical Device Recall Notifications with the revised Instructions for Use (IFU).
The revised IFU contains the following Neptune Waste Management updated warning information: WARNING: DO NOT apply High Flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction, for example, passive chest drainage. ALWAYS consider the type of tissue associated with the surgical procedure BEFORE using this system. Failure to comply may result in severe injury or death.
The notice directed customers to distribute the notification and updated IFU to all departments, discarding earlier revision of the IFU.
In addition, customers were asked to complete, sign and return a business reply form to Angela Ragainis, Recall Coordinator by fax to 1-866-521-2762 or email at firstname.lastname@example.org.
On August 15, 2012, the FDA issued a Class I recall of the Neptune 1 Bronze, Neptune 1 Silver, Neptune 1 Gold, Neptune Gold International and Neptune 2 Ultra Waste Management Systems, the most serious type of recall. This recall included the following revised Instructions for Use Warning: Do Not apply High Flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction. All Neptune 1 Bronze, Neptune 1 Gold and Neptune 1 Gold International customers should have received warning labels to apply to the device in an updated notice mailed to customers on Sept. 25, 2012. However, FDA advised that the Neptune 2 devices not be used because they do not have 510(k) clearance. 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 Neptune 2 (230V), they must complete a Certificate of Medical Necessity by October 26, 2012.
On October 5, 2012, The FDA issued a safety communication about the Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems. Only customers that complete the Certificate of Medical Necessity can use and will receive warning labels for the Neptune 1 Silver and Neptune 2 Ultra devices.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
- FDA Safety Communication: Neptune 1 Silver Waste Management System and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra)
- Firm Press Release