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Centurion

CENTURION MEDICAL PRODUCTS CORPORATION · Model PE525 · UDI-DI 00653160088694

MLT Prescription
1
510(k) clearances
1
Adverse events
10
Recalls
23
Facilities

Recalls

DateFirmReason
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac
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.
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.
2024-10-09MEDLINE INDUSTRIES, LP - NorthfieldMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
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
2023-05-30DeRoyal Industries IncThe outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
2022-11-17MEDLINE INDUSTRIES, LP - NorthfieldSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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
2019-12-11Centurion Medical Products CorporationIncomplete seals on the sterile package may compromise the sterility

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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.