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Couplet Care Bassinet

Couplet Care, Inc. · Model CCB0100 · UDI-DI 00199284746916

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

Description

The Couplet Care Bassinet is for use in hospitals and birthing centers. It creates a bridge for mother-infant connection. This access is important for infant feeding, safe sleep, and maternal healing.

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.