FDA Device recall Z-0530-2021
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precis…
- 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 - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precis… 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-0530-2021 |
| 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 - T34 - 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 T34 - Part Number(s) 100-100PS; 100-100PSA; 100-100POBSC; 100-101PS Serial Number: 58771 58772 58773 58774…Model T34 - Part Number(s) 100-100PS; 100-100PSA; 100-100POBSC; 100-101PS Serial Number: 58771 58772 58773 58774 58775 58776 58777 58778 58779 58780 58781 58782 58783 58784 58785 58786 58787 58788 58789 58790 26478 S26442 S26443 S26444 26305 26307 26309 26310 26311 26312 26313 26314 26315 26316 26317 26318 26319 26320 26321 26322 26335 26323 26324 26325 26326 26327 26328 26329 26330 26331 26332 26333 26334 26336 26337 26338 26339 26340 26341 26342 26343 26344 26345 26346 26347 26348 26349 26350 26351 26352 26353 26354 26355 26356 26357 26358 26360 26361 26362 26363 26364 26365 26366 26367 26368 26369 26370 26371 26372 26373 26374 26375 26376 26377 26378 26379 26380 26381 26382 26383 26384 26386 26387 26388 26389 26390 26391 26392 26393 26394 26395 26396 26397 26398 26399 26400 26401 26402 26404 26405 26407 26408 S26261 S26262 S26263 S26264 S26265 S26266 261 |
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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-0530-2021%22
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