CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report
Medstream 81" 20 drop Universal Administration Sets recalled
US Infusion is recalling Medstream 81" 20 drop Universal Administration Sets, distributed in California, Georgia, Illinois, Massachusetts, Ohio, Texas. The recall was initiated on 10 Oct 2014 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-1277-2015
- FDA event ID
- 70143
- Recalling firm
- US Infusion, South Miami, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2014
- FDA classified
- 13 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Infusion Pumps
Timeline
| 10 Oct 2014 | Recall initiated by company | |
| 13 Mar 2015 | Classified by FDA | +154 days |
| 25 Mar 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Several complaints regarding the IV sets leaking at the Y site.
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
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Where it was distributed
Distributed in the states of TX, IL, MA, OH, CA, and GA.
Questions about this recall
Is Medstream 81" 20 drop Universal Administration Sets recalled?
Yes. US Infusion recalled Medstream 81" 20 drop Universal Administration Sets on 10 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-1277-2015.
Why was it recalled?
Several complaints regarding the IV sets leaking at the Y site.
Which lots are affected?
Model # MS721, Lot # 20111115.
Where was it sold?
Distributed in the states of TX, IL, MA, OH, CA, and GA.
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.
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |