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NeoLight Bassinet Basket Loaner

NEOLIGHT LLC · Model 300064 · UDI-DI 00852788008101

NZG Prescription
0
510(k) clearances
104
Adverse events
2
Recalls
25
Facilities

Description

The NeoLight Bassinet Basket Loaner is a component of a non-powered medical bassinet, intended to work effortlessly with Stryker’s Nära Bassinet’s wheeled base and mattress, offering an adjustable sleeping surface for infants. Constructed from clear, durable, BPA-free high-impact resistant plastic, the basket features an open top and four fixed walls to securely hold the pediatric patient.

Recalls

DateFirmReason
2018-10-10Stryker Medical Division of Stryker CorporationIt was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patien
2011-10-14Nemschoff Chairs, Inc.To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassin

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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.