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ACE-FL

ALLWIN MEDICAL DEVICES, INC. · Model ACE Single Lumen Ovum Pick-up Needle 16G, 35cm with Flushing Line · UDI-DI 00819374021777

MQE Prescription
1
510(k) clearances
163
Adverse events
1
Recalls
28
Facilities

Description

ACE Single Lumen Ovum Pick-up Needle 16G, 35cm with Flushing Line

Recalls

DateFirmReason
2008-10-23Irvine Scientific Sales Co IncSmiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.