Manometer — Class II medical device recall Z-1421-2018
Terminated recall by Carefusion 2200 Inc, reported 2018-04-25, distributed nationwide. The integrity of the sterile packaging is potentially compromised.
| Recall number | Z-1421-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2017-02-23 |
| Classified | 2018-04-18 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CA, CN, JP, KW, MX, MY, NL, NZ, PH, SG, TH, TW, VN, ZA |
| Quantity | 4,240 units |
| Reason classes | sterility |
| Lot numbers | 0000837810, 0000840335, 0000842213, 0000848531, 0000851181, 0000853962 |
Product
Manometer, 550 ml three-Way Stopcock; STERILE;
Reason for recall
The integrity of the sterile packaging is potentially compromised.
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-1421-2018. 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.