CLASS II Device recall · Reported 5 Oct 2016 · FDA Enforcement Report
Administration Set, Sterile recalled by Zyno Medical
Zyno Medical is recalling Administration Set, Sterile, distributed nationwide in the US. The recall was initiated on 29 Jul 2016 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-2894-2016
- FDA event ID
- 74892
- Recalling firm
- Zyno Medical, Natick, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2016
- FDA classified
- 27 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 29 Jul 2016 | Recall initiated by company | |
| 27 Sep 2016 | Classified by FDA | +60 days |
| 5 Oct 2016 | 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 Set potential filter leaking
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Administration Set potential filter leaking
Which lots are affected?
Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499
Where was it sold?
US Nationwide Distribution
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 74892This product is part of a recall event; the main page for the event is Administration Set, Sterile recalled by Zyno Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Administration Set, Sterile recalled by Zyno Medical | Zyno Medical | Packaging Defects | Nationwide | |
| CLASS II | Administration Set Sterile recalled by Zyno Medical | Zyno Medical | Packaging Defects | Nationwide | |
| CLASS II | Administration Set, Sterile recalled by Zyno Medical | Zyno Medical | Packaging Defects | Nationwide |
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 |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |