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Breast Biopsy / Localization Tray

FDA product code PXP · Class 1 · General, Plastic Surgery

138
Registered devices
2
Adverse events
8
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
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 bee
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 bee
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 bee
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr
2023-05-18MEDLINE INDUSTRIES, LP - NorthfieldProbe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2023-05-15MEDLINE INDUSTRIES, LP - NorthfieldPotential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2019-12-11Centurion Medical Products CorporationIncomplete seals on the sterile package may compromise the sterility
2019-12-11Centurion Medical Products CorporationIncomplete seals on the sterile package may compromise the sterility

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.