P400 PREM U/M 16FR TMPSNS — Class II medical device recall Z-3208-2018
Terminated recall by COVIDIEN LLC, reported 2018-09-26, distributed in CA, CO, FL, GA, IA, IL, IN, KY…. The temperature sensor catheters may be defective in that they will show a lower body temperature measurement
| Recall number | Z-3208-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2018-07-11 |
| Classified | 2018-09-20 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-08-03 |
| Distributed | CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA |
| Quantity | 27,515 total |
| Model numbers | P4P16TS |
Product
P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
Reason for recall
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
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-3208-2018. 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.