The Recall Desk
CriticalFDA (Devices)·Z-2063-2012·Announced 2012-08-22

Stryker Neptune Waste Management System Recall Due to Tissue Injury and Fatality

Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly reports a fatality and serious injuries, which meets the rubric criteria for a Critical severity score of 5.

Plain-English summary

Stryker Instruments Division of Stryker Corporation is recalling the Neptune Bronze Rover Waste Management System Instructions for Use (Part 0700-007-000). The recall involves 1,075 units distributed nationwide in the United States and in Canada. The instructions were intended for use in surgical environments or physician's offices to collect and dispose of surgical fluid waste.

The recall was initiated after Stryker received two reports of serious injury resulting in tissue damage associated with the use of the Neptune 2 system. One of these events resulted in a fatality when a customer connected the Neptune 2 System to a passive chest drainage tube post-operatively. The original instructions did not specifically warn against connecting high vacuum/high flow Neptune devices to passive drainage tubes. Additionally, further investigation revealed that the Neptune 1 Silver, Neptune 2 Ultra (120V), and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance, meaning they were not legally marketed without a determination of safety and effectiveness.

Customers were instructed on June 12, 2012, to review the revised instructions, distribute them to affected departments, and educate users on the new warning. Warning labels are required on all Neptune devices. The FDA advises that the Neptune 1 Silver, Neptune 2 Ultra (120V), and Neptune 2 Ultra (230V) not be used. However, customers without an alternative device should weigh the risks and benefits of continued use. If customers choose to continue using these specific devices, they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.

The recalled product

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.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Waste Management
Hazard
Affected units
1,075

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part : 0700-007-000
  • all lot numbers IFU Part number 0700-007-720

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same hazard · tissue damage

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