Pressure Monitoring Kit — Class II medical device recall Z-0634-2017
Terminated recall by Merit Medical Systems, Inc., reported 2016-11-30, distributed nationwide. Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to
| Recall number | Z-0634-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2016-09-23 |
| Classified | 2016-11-19 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 130 units |
| Reason classes | sterility |
| Lot numbers | H996490 |
| Model numbers | K11-00232G |
Product
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Reason for recall
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
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-0634-2017. 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.