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HomeDARCO INTERNATIONAL, INC. › CRADLE SLING ECONOMY

CRADLE SLING ECONOMY

DARCO INTERNATIONAL, INC. · Model 422-0025-20 · UDI-DI 00609271020719

ILI
10
510(k) clearances
26
Adverse events
5
Recalls
334
Facilities

Description

Pediatric

Recalls

DateFirmReason
2021-04-12DJ Orthopedics de Mexico S.A. de C.V.failed rivet at the chafe tab of arm sling.
2021-04-12DJ Orthopedics de Mexico S.A. de C.V.failed rivet at the chafe tab of arm sling.
2021-04-12DJ Orthopedics de Mexico S.A. de C.V.failed rivet at the chafe tab of arm sling.
2021-04-12DJ Orthopedics de Mexico S.A. de C.V.failed rivet at the chafe tab of arm sling.
2016-10-31Owens & Minor Distribution, Inc.Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc.

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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.