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Aero-Med

AERO-MED, LLC · Model CA30000 · UDI-DI 10885380177057

OIB
0
510(k) clearances
7
Adverse events
28
Recalls
42
Facilities

Description

Blood Culture Collection Kit, Line Draw, Steripath, Russell Memorial Only

Recalls

DateFirmReason
2026-07-20Medline Industries, LPDownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the ap
2026-06-12Medline Industries, LPThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi
2026-06-12Medline Industries, LPThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi
2026-03-16Medline Industries, LPMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web
2026-03-09LSL Healthcare Inc.Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
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
2025-12-24Medline Industries, LPMedline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on th
2025-06-12MEDLINE INDUSTRIES, LP - NorthfieldAffected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a
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

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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.