Z-0527-2021Class II

CME America T-Syringe Pump - T34L PCA -

Name: Z-0527-2021 CME America T-Syringe Pump - T34L PCA -
Creator: CME America, LLC
Published: 2020-07-30
License: https://open.fda.gov/license/

CME America, LLC / initiated 2020-07-30 / Terminated

FDA source

CME America, LLC began a recall of CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled... on 2020-07-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0527-2021
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Posted: 2020-12-03
Terminated: 2022-03-08
Recalling firm: CME America, LLC
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).
Product code: FRN Pump, Infusion
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.
FDA root cause: Other
Action: On July 30, 2020, the firm sent an "URGENT MEDICAL DEVICE RECALL CORRECTION" Notification Letter via FedEx to customers informing them of two issues: Issue 1: The motor block mechanism may be affected over time by normal wear and tear which may cause the device to stop without alarms being generated. Issue 2: Due to routine cleaning and disinfection, there is a potential for fluid to ingress into the pump and over time, could result in damage to the pump components leading to inoperability of the device. For this issue the device will stop and will alarm. The Recalling Firm is instructing customers to: For Issue 1: Inspect the lead screw to detect the presence of white plastic debris. Inspection must be performed prior to each use of the affected pumps. If signs of wear and tear are observed, discontinue use of the pump and contact the Recalling Firm for product removal. For Issue 2: Follow the Manufacturer Recommended Cleaning instructions in Appendix A and the Technical Service Manual instructions for preventive maintenance provided in Appendix B of the attached Customer Letter to limit the cumulative effects of fluid ingress over time. Immediate Actions to Take: 1) Please refer to the attached customer communication regarding this recall action. 2) As the Recalling Firm plans to notify all affected customers directly, customers are asked to identify customers within their distribution network that purchased the affected product, as defined in the recall notification. Email an excel file listing of all customers to [email protected] within 72 hours of receipt of this letter so that the Recalling Firm may initiate customer notification. 3) Complete the attached Distributor Response Form and return to the Recalling Firm's contact noted on the form whether or not the customers have any of the impacted material so that the Recalling Firm may acknowledge the receipt of this notification. 4) Contact the Recalling Firm to arrange for the return of all in sto
Quantity in commerce: Total pumps = 4,182 (all models)
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0527-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0525-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03
Z-0526-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03
Z-0527-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03
Z-0528-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03
Z-0529-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03
Z-0530-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03

Product code FRN

K080954Class IIT34l Syringe DriverCaesarea Medical Electronics , Ltd. / cleared 2008-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)