FDA Device recall Z-0527-2021
CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at p…
- 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 - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at p… 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-0527-2021 |
| 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 - T34L PCA - 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 T34L PCA - Part Number(s) (UDI Codes) 100-106PSL (UDI Code: B101100106PSL0) Serial Number: 26486 26485 2648…Model T34L PCA - Part Number(s) (UDI Codes) 100-106PSL (UDI Code: B101100106PSL0) Serial Number: 26486 26485 26484 S93716 100-106PSLM (retired prior to UDI) |
|---|
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-0527-2021%22
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