FDA Device recall Z-2197-2014
Prisma M 100 PRE set
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of Prisma M 100 PRE set by Gambro Renal Products, citing gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2197-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-18 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Gambro Renal Products |
| Distribution | n/a |
Product
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
Reason
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Identifiers
| code_info | Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2197-2014%22
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