CME America T-Syringe Pump -T34L — Class II medical device recall Z-0525-2021
Terminated recall by CME America, LLC, reported 2020-12-09, distributed nationwide. Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations
| Recall number | Z-0525-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CME America, LLC, Golden, CO, United States |
| Recall initiated | 2020-07-30 |
| Classified | 2020-12-03 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4,182 |
| Reason classes | packaging |
| Serial numbers | 26130, 26132, 26133, 26294, 26295, 26296, 26297, 26298, 26299, 26300, 26301, 26302, 26304, 26428, 26479, 58765, 58766, 58906, 58907, 58909, 58910, 58911, 58912, 58913, 58914 and 115 more |
| Model numbers | 100-100PSLA, 100-101PSLA, TR34L |
Product
CME America T-Syringe Pump -T34L - 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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0525-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.