Z-800W Infusion System Recalled for Unvalidated Software Installation
Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class I recall of a medical device used for critical infusion therapy. The unvalidated software on a device intended to deliver blood and parenteral fluids poses a significant risk of harm, meeting the Severe criteria for FDA Class I recalls even without reported injuries.
Plain-English summary
The Z-800W Infusion System, which is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to patients, is being recalled by Zyno Medical LLC.
The recall affects 613 units of the Z-800W model (UDI-DI: 00814371020020) that were distributed nationwide. The reason for the recall is that unreleased software versions were installed on distributed devices without verification or validation.
If you are a healthcare facility or patient using this infusion system, contact Zyno Medical LLC or the FDA for instructions on the appropriate next steps and any remediation options available.
The recalled product
- Product
- Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Manufacturer
- Zyno Medical LLC
- Category
- Medical Device — Infusion System
- Hazard
- software-validation
- unvalidated-firmware
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: Z800W
- UDI-DI
- 00814371020020
- Serial No. 700063
- 700163
- 700203
- 700402
- 700488
- 700093
- 700169
- 700210
- 700428
- 700495
- 700104
- 700172
- 700214
- 700431
- 700503
- 700111
- 700188
Distribution
Distributed nationwide across the United States.
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