The Recall Desk
CriticalFDA (Devices)·Z-2062-2012·Announced 2012-08-22

Stryker Neptune 1 Gold Rover Waste Management System Recalled for Injury Risk

Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.

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 states that one event resulted in a fatality, which mandates a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling the Neptune 1 Gold Rover (120V and 230V) Waste Management System. The recall involves 5,925 domestic units and 2 international units distributed nationwide in the USA and in Canada. The devices are 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 from 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 Instructions for Use (IFU) did not specifically warn against connecting Neptune Waste Management devices, which are high vacuum/high flow devices, to passive drainage tubes.

Customers were instructed on June 12, 2012, to review the revised IFU, distribute it to affected departments, and educate users on this warning. Warning labels are required on all Neptune devices and are pending distribution. Additionally, the FDA advised that the Neptune 1 Silver, Neptune 2 Ultra (120V), and Neptune 2 Ultra (230V) should not be used because they lacked FDA 510(k) clearance. Customers who choose to continue using these specific uncleared devices must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.

The recalled product

Product
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid was
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Waste Management System
Hazard

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 (1)

  • 120V Gold part numbers 0700-001-000 IFU 0700-001-700 230 V Gold 0700-002- 000

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 →

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · tissue damage

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