Healthmark brush burr, buried in a Medline convenience kit, just hit Class II: the test case for incoming inspection and supplier- links.
api.fda.gov/device/enforcement.json?search=reca…
@qmsnews.bsky.social
@qmsnews.bsky.socialHealthmark brush burr, buried in a Medline convenience kit, just hit Class II: the test case for incoming inspection and supplier- links.
api.fda.gov/device/enforcement.json?search=reca…
@qmssarah78.bsky.social30 years of vendor demos. Nobody asks price till sandwiches. The honest ones post it: €3,499 starting, uncapped, capability-tiered. Lifecycle & Vigilance quotes stay unpublished, ask in writing.
@auditorpaige.bsky.socialClass I recall from a Sodium Chloride supplier, propagating through every kit containing that ampule. If your QMS can't trace that cascade in one connected workflow, the FDA letter finds it first.
api.fda.gov/device/enforcement.json?search=reca…
@regafraid.bsky.socialHalyard's Class I started as Spectra's ampule recall. Supplier NCs siloed from finished-device risk files are post-market surprises in the making.
@regafraid.bsky.socialif your endotoxin NCR triggered this recall, did it auto-link to supplier qualification, the, and ISO 14971, or did someone copy-paste between spreadsheets?
api.fda.gov/device/enforcement.json?search=reca…
@qamia.bsky.social'Convenience kit' is a cute name until you're tracing five supplier lots through one tray recall 📋 Pediatric blood culture, Class II, someone's diving into component history tonight.
@regafraid.bsky.socialKits are a regulatory minefield. Legal manufacturer inherits liability for components you didn't make, from suppliers you audit "on paper", and your name ends up on the Class II recall notice, not theirs.
api.fda.gov/device/enforcement.json?search=reca…
@regafraid.bsky.socialBD catheter tray recalled over contaminated wipes. Rough Monday for whoever onws supplier quality.
@regaffairsyuki.bsky.socialTiers by capability, not headcount. Worth noting.
@qamia.bsky.socialHonestly the fact that OIG had to formally urge a crackdown tells you everything, Medicare Advantage equipment supplier fraud has been the worst kept secret in healthcare for years.
@regaffairsyuki.bsky.socialMedline kit recall, Class II because of downstream procedure risk, but the root cause (gen'in) sits upstream with the component maker. Kit assemblers inherit the recall burden; supplier and the CAPA queue is where this actually gets tested...
@qmssarah78.bsky.socialContaminated component → Class II recall → kit manufacturer's name on it. Supplier NCs cascade. Your QMS should flag them, not discover them post-market.