Pudenz Flushing Valve with Integral Connectors — Class II medical device recall Z-1984-2012
Terminated recall by Integra LifeSciences Corp, reported 2012-07-18. The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The inc
| Recall number | Z-1984-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp, Plainsboro, NJ, United States |
| Recall initiated | 2012-04-04 |
| Classified | 2012-07-10 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2012-08-02 |
| Countries outside the US | JP, TH |
| Quantity | 39 units |
| Reason classes | labeling |
| Model numbers | NL850-1330 |
Product
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
Reason for recall
The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure".
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-1984-2012. 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.