CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
Administration Set -105"Admin Set 20DP W/Filter 2YSITES recalled
Zyno Medical is recalling Zyno Medical Administration Set -105"Admin Set 20DP W/Filter 2YSITES Clmp- For Use with, distributed in Massachusetts. The recall was initiated on 29 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2059-2019
- FDA event ID
- 83026
- Recalling firm
- Zyno Medical, Natick, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2019
- FDA classified
- 23 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 29 May 2019 | Recall initiated by company | |
| 23 Jul 2019 | Classified by FDA | +55 days |
| 31 Jul 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
Product as listed by the FDA
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
Where it was distributed
MA
Questions about this recall
Is Administration Set -105"Admin Set 20DP W/Filter 2YSITES Clmp- For Use with Zyno Medical recalled?
Yes. Zyno Medical recalled Administration Set -105"Admin Set 20DP W/Filter 2YSITES Clmp- For Use with Zyno Medical on 29 May 2019. The recall is Class II and its status is Terminated. Recall number Z-2059-2019.
Why was it recalled?
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
Which lots are affected?
Lot Numbers: 18046309, 18026344 UDl/UPC/GTIN: 00814371020204
Where was it sold?
MA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zyno Medical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Z-800F Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Z-800W Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Z-800WF Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Z-800 Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
| Device | CLASS III | Z-800 Infusion System Z-800WF recalled by Zyno Medical | Zyno Medical | Device Malfunction | 8 states |
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| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |