BARD — Class II medical device recall Z-0565-2018
Terminated recall by C.R. Bard, Inc., reported 2018-02-21. BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volu
| Recall number | Z-0565-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2017-11-10 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2021-09-22 |
| Countries outside the US | JP |
| Quantity | 343 units |
| Serial numbers | DYAPAA001, DYAPAA002, DYAPAA003, DYAPAA004, DYAPAA005, DYAPAA006, DYAPAA007, DYAPAA008, DYAPAA009, DYAPAA010, DYAPAA011, DYAPAA012, DYAPAA013, DYAPAA014, DYAPAA015, DYAPAA016, DYAPAA017, DYAPAA018, DYAPAA019, DYAPAA020, DYAQAA001, DYAQAA002, DYAQAA003, DYAQAA004, DYAQAA005 and 466 more |
| Model numbers | 000002N |
Product
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Reason for recall
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
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-0565-2018. 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.