20 results
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8ms
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Sources: EU EUDAMED, US FDA
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·March 16, 2022
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·September 25, 2024
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·July 31, 2024
Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·August 26, 2020
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·February 4, 2026
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024