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Curaplex

BOUND TREE MEDICAL, LLC · Model 8600-01251 · UDI-DI 00817617028156

PAD Prescription
0
510(k) clearances
19
Adverse events (3 deaths)
20
Recalls
23
Facilities

Description

*Custom* Curaplex First Flight Chest Tube Kit

Recalls

DateFirmReason
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-03-03MEDLINE INDUSTRIES, LP - NorthfieldThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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
2016-11-29Atrium Medical CorporationOuter Packaging is not sterile
2016-11-29Atrium Medical CorporationOuter Packaging is not sterile
2016-11-29Atrium Medical CorporationOuter Packaging is not sterile
2016-11-29Atrium Medical CorporationOuter Packaging is not sterile

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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.