FDA Device recall Z-0528-2021
CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at pr…
- FDA Device
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at pr… by Cme America, citing multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardwa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0528-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-30 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cme America |
| Distribution | US |
Product
CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
Reason
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
Identifiers
| code_info | Model Neofeed - Part Number(s) 100-109PSL1A; 100-109PSLA; 100-110PSLA UDI Codes: B101100109PSLA0 B101100109SL1A0…Model Neofeed - Part Number(s) 100-109PSL1A; 100-109PSLA; 100-110PSLA UDI Codes: B101100109PSLA0 B101100109SL1A0 B101100110PSLA0 Serial Number: 58767 58763 58761 26410 26439 26447 26456 26460 26461 26462 26463 26464 26465 26158 26157 26159 26160 26161 26134 26135 23136 26047 26008 26055 26054 26053 26048 26036 26050 26031 26035 26028 26007 26022 26014 26033 26012 26005 26023 26002 26000 26024 26034 25998 26010 26001 26009 26003 26015 26004 26006 26016 25930 25931 25932 25933 25938 25939 25960 25961 25962 25963 25964 25965 25966 25967 25969 25970 25971 25972 25973 25974 25975 25976 25977 25978 25979 25980 25981 25982 25983 25984 25985 25986 25987 25988 25989 25990 25991 25992 25993 25995 25996 25936 25935 25947 25968 25956 25949 25943 25954 25948 25934 25951 25945 25944 25953 25946 25952 25959 25957 25950 25958 25941 25955 25942 25937 25901 25903 25897 25900 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0528-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.