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INHANCE INTACT

DEPUY (IRELAND) · Model 6231-31-303 · UDI-DI 10603295559696

FSH
8
510(k) clearances
68
Adverse events (4 deaths)
7
Recalls
22
Facilities

Description

INHANCE INTACT INSTRUMENT CASE COMPLETE

Recalls

DateFirmReason
2026-05-21Bard Access Systems, Inc.Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2017-02-23Carefusion 2200 IncThe integrity of the sterile packaging is potentially compromised.
2017-02-23Carefusion 2200 IncThe integrity of the sterile packaging is potentially compromised.
2017-02-23Carefusion 2200 IncThe integrity of the sterile packaging is potentially compromised.
2017-02-23Carefusion 2200 IncThe integrity of the sterile packaging is potentially compromised.
2017-02-23Carefusion 2200 IncThe integrity of the sterile packaging is potentially compromised.

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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.