Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa
FDA device recall Z-1866-2025 · posted 2025-06-06 · Open, Classified
Recall details
- Recalling firm
- Zyno Medical LLC
- Reason for recall
- Unreleased software versions were installed on distributed devices without verification or validation.
- Action taken
- Consignees received an "URGENT: MEDICAL DEVICE CORRECTION" notification dated 5/7/25 by email. The notification instructs consignees to check their stock for affected devices and to immediately stop use; recalled devices are to be returned to Zyno Medical via the provided Response Verification Form. The recall notice is to be provided to personnel at consignee locations who need to be informed and communicated to facilities to where devices were transferred to. Any questions about this recall action are to be directed via email to Frederick Lee at feedback@intuvie.com. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.
- Root cause
- Software design (manufacturing process)
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 613 units
- Distribution
- US Nationwide
- Date initiated
- 2025-05-07
- Date posted
- 2025-06-06
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Z-800 INFUSION SYSTEM (K130690) | Zyno Medical, LLC | 2013-06-12 |
| ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (K100705) | Zyno Medical, LLC | 2010-07-08 |