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Integra® Jarit®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 500125 · UDI-DI 10381780394792

HDF Prescription
10
510(k) clearances
44
Adverse events
3
Recalls
227
Facilities

Description

Integra® Jarit® Pederson Vaginal Speculum, 6", Large Blades, 5" x 1"

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2023-03-16Carefusion 2200 IncA portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
2019-07-01Centurion Medical Products CorporationPotential for sterile packaging to be 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.