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CVS/Pharmacy

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Model NS14 · UDI-DI 00050428358689

JCX

510(k) clearances

2,154

Adverse events (53 deaths)

Recalls

Facilities

Description

A portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a hand grip that contains the batteries, a small electric pump that creates the suction, and a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.

Recalls

Date	Firm	Reason
2026-05-06	Stryker Corporation	It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being ship
2026-01-13	Laerdal Medical Corporation	units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Categor
2020-12-18	Laerdal Medical (Suzhou) Co., Ltd.	Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenar
2017-08-31	Laerdal Medical Corporation	A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms
2017-01-08	Laerdal Medical Corporation	The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
2016-07-01	Stryker Instruments Div. of Stryker Corporation	Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if hi
2016-05-23	DeVilbiss Healthcare LLC	A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
2015-06-04	Gardner Denver Thomas Inc	Vacuum pump may not perform to specification.
2015-06-04	Gardner Denver Thomas Inc	Vacuum pump may not perform to specification.
2015-06-04	Gardner Denver Thomas Inc	Vacuum pump may not perform to specification.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.