Prisma M 60 PRE set — Class II medical device recall Z-2195-2014
Terminated recall by Gambro Renal Products, Incorporated, reported 2014-08-20. Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in
| Recall number | Z-2195-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gambro Renal Products, Incorporated, Lakewood, CO, United States |
| Recall initiated | 2014-07-18 |
| Classified | 2014-08-13 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2015-02-05 |
| Quantity | 401,451 |
| Reason classes | packaging |
| Lot numbers | 12K1205G, 14B1003 |
| Expiration dates | 2014-11 |
Product
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Reason for recall
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
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-2195-2014. 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.