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V. Mueller

CAREFUSION 2200, INC · Model GP4-3200 · UDI-DI 10885403047787

KCT
10
510(k) clearances
344
Adverse events
38
Recalls
296
Facilities

Description

V. Mueller LAPCARE LONG LAPCARE TO FIT 16 LAP INSTRUMENTS FROM 5MM TO 10MM IN DIAMETER.

Recalls

DateFirmReason
2025-05-23Jewel Precision Sheet Metal & Machining Co, Inc.The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the ch
2025-05-22Jewel Precision Sheet Metal & Machining Co, Inc.The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
2025-05-01Implant Direct Sybron Manufacturing LLCThe Drill stop kit contains incorrect components.
2023-04-06Karl Storz EndoscopyMetal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tra
2023-04-05Karl Storz EndoscopyPlastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the t
2023-01-30Carefusion 2200 IncProduct did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
2022-09-26Carefusion 2200 IncGenesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
2022-09-26Carefusion 2200 IncGenesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
2022-09-26Carefusion 2200 IncGenesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
2022-09-26Carefusion 2200 IncGenesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

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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.