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Curaplex

BOUND TREE MEDICAL, LLC · Model 8600-01480 · UDI-DI 00810071631924

BTQ Prescription
10
510(k) clearances
312
Adverse events (3 deaths)
2
Recalls
126
Facilities

Description

*Custom* Curaplex NPA Kit 4 Sizes w/ Lubricating Jelly

Recalls

DateFirmReason
2024-07-18Smiths Medical ASD Inc.Uncertainty in the seal integrity of the sterile packaging.
2017-01-13Teleflex MedicalLabeling error

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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.