FDA Device recall Z-0529-2021
CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermitt…
- 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 - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermitt… 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-0529-2021 |
| 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 - Ameritus 1st Enteral Pump - 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 Ameritus 1st Enteral Pump - Part Number(s) AEG-1PUMP Serial Number: 58791 58770 58769 58768 58760 26417…Model Ameritus 1st Enteral Pump - Part Number(s) AEG-1PUMP Serial Number: 58791 58770 58769 58768 58760 26417 26480 26481 26482 26483 26466 26467 26468 26469 26470 26471 26472 26473 26474 26475 26476 26477 26453 26454 26457 26448 26452 26449 26458 26455 26451 26459 26450 26445 26446 26440 26441 26427 26419 26420 26421 26422 26423 26424 26425 26426 26411 26413 26414 26416 26283 26284 26285 26286 26287 26288 26289 26290 26291 26292 26293 26281 26282 26252 26255 26254 26257 26250 26251 26256 26253 26249 26248 26267 26242 26243 26244 26245 26246 26247 26212 26215 26216 26217 26218 26219 26220 26221 26222 26223 26224 26225 26226 26227 26228 26229 26230 26231 26232 26233 26234 26235 26236 26237 26238 26239 26240 26162 26165 26166 26167 26169 26170 26172 26175 26176 26177 26180 26181 26182 26183 26184 26186 26163 26164 26168 26171 26173 26174 26178 26179 26185 |
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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-0529-2021%22
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