System/Device, Pharmacy Compounding
FDA product code NEP · Class II (moderate risk) · 21 CFR 880.5440 · General Hospital
0510(k) clearances
0PMA approvals
40recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2262-2026 Class II | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number:…Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated… | Baxter Healthcare Corporation | 04/22/2026Open, Classified |
| Z-2047-2026 Class I | Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028…Potential for mislabeled syringe produced by the i.v.STATION device. | Omnicell, Inc. | 03/25/2026Open, Classified |
| Z-1617-2023 Class II | Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures…IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation… | OmniCell, Inc. | 03/27/2023Open, Classified |
| Z-1376-2022 Class I | ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167…There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. | Baxter Healthcare Corporation | 06/22/2022Terminated |
| Z-1475-2021 Class II | ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1472-2021 Class II | Left Heart Kit, Model Number M20268. for blood pressure monitoring.Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-0719-2021 Class II | APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product…There is the potential for the compounding system to not immediately interrupt compounding and alert user to… | B Braun Medical, Inc. | 11/23/2020Terminated |
| Z-0718-2021 Class II | APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product…There is the potential for the compounding system to not immediately interrupt compounding and alert user to… | B Braun Medical, Inc. | 11/23/2020Terminated |
| Z-0717-2021 Class II | APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product…There is the potential for the compounding system to not immediately interrupt compounding and alert user to… | B Braun Medical, Inc. | 11/23/2020Terminated |
| Z-2343-2018 Class II | 26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set… | B. Braun Medical, Inc. | 06/04/2018Terminated |
| Z-0989-2017 Class II | i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy…The firm has initiated a product correction due to a bag carousel motor error causing misalignment and… | Health Robotics S.R.L. | 11/23/2016Terminated |
| Z-2264-2016 Class II | Container fill and transfer sets, 250 mL and 500 mL, . .An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-2263-2016 Class II | Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300…An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-2262-2016 Class II | Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mLAn issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-2261-2016 Class II | Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL…An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-2260-2016 Class II | Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-2259-2016 Class II | AUTOCOMP6 High Speed CompounderAn issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-2258-2016 Class II | AUTOCOMP6 XP High Speed Compounder REF 58810An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-2257-2016 Class II | AUTOCOMP6 XPS High Speed Compounder REF 58810An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | The Metrix Company | 06/23/2016Terminated |
| Z-1369-2016 Class II | Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an…ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the… | ICU Medical, Inc. | 03/08/2016Terminated |
| Z-1368-2016 Class II | Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000…ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the… | ICU Medical, Inc. | 03/08/2016Terminated |
| Z-1367-2016 Class II | Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an…ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the… | ICU Medical, Inc. | 03/08/2016Terminated |
| Z-1366-2016 Class II | Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an…ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the… | ICU Medical, Inc. | 03/08/2016Terminated |
| Z-1365-2016 Class II | Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST…ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the… | ICU Medical, Inc. | 03/08/2016Terminated |
| Z-1364-2016 Class II | Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an…ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the… | ICU Medical, Inc. | 03/08/2016Terminated |
| Z-0607-2016 Class II | Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access…Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or… | Baxter Healthcare Corp. | 11/30/2015Terminated |
| Z-1628-2015 Class II | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product…Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that… | Baxter Corporation Englewood | 04/08/2015Terminated |
| Z-1847-2014 Class II | Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for…Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when… | Baxter Corporation Englewood | 05/28/2014Terminated |
| Z-1566-2014 Class I | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator…1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the… | Baxter Corporation Englewood | 04/02/2014Terminated |
| Z-0607-2014 Class II | IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL…Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill… | Baxter Healthcare Corp. | 11/08/2013Terminated |
| Z-0156-2013 Class II | Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution…The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because… | Baxa Corporation | 10/03/2012Terminated |
| Z-2142-2012 Class I | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated…After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may… | Baxter Healthcare Corp. | 07/13/2012Terminated |
| Z-2141-2012 Class I | AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated…After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may… | Baxter Healthcare Corp. | 07/13/2012Terminated |
| Z-2140-2012 Class I | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition…After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may… | Baxter Healthcare Corp. | 07/13/2012Terminated |
| Z-2139-2012 Class I | AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders…After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may… | Baxter Healthcare Corp. | 07/13/2012Terminated |
| Z-1389-2012 | Pharmacy compounding system . It is a twenty-four source compounder for multi-source…Software issue with compounding pump resulting in over delivery of component ingredients during routine… | Baxa Corporation | 03/23/2009Terminated |
| Z-1371-2012 | The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for…Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM… | Baxa Corporation | 06/03/2008Terminated |
| Z-1371-2008 | Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple…Flush solution from TPN compounder may be added to patient's TPN bag. | Baxa Corporation | 02/11/2008Terminated |
| Z-1370-2008 | Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound…Flush solution from TPN compounder may be added to patient's TPN bag. | Baxa Corporation | 02/11/2008Terminated |
| Z-1238-2007 | Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa…A software defect could allow up to 50mL of extra volume being added to a TPN solution. | Baxa Corporation | 06/27/2007Terminated |