CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
Nimbus Administration Set recalled by InfuTronix
InfuTronix is recalling Nimbus Administration Set, distributed in Massachusetts. The recall was initiated on 28 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-2055-2019
- FDA event ID
- 82997
- Recalling firm
- InfuTronix, Natick, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2019
- FDA classified
- 23 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 28 May 2019 | Recall initiated by company | |
| 23 Jul 2019 | Classified by FDA | +56 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
Potential for tube leakage
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
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
Where it was distributed
US distribution in the state of MA
Questions about this recall
Is Nimbus Administration Set recalled?
Yes. InfuTronix recalled Nimbus Administration Set on 28 May 2019. The recall is Class II and its status is Terminated. Recall number Z-2055-2019.
Why was it recalled?
Potential for tube leakage
Which lots are affected?
1) Lot # 1805002, Exp Date 06/10/2021, 2) Lot # 1712005, Exp Date 12/19/2020, 3) Lot # 1710012, Exp Date 10/22/2020, 4) Lot # 1901003, Exp Date 01/07/2022
Where was it sold?
US distribution in the state of 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 InfuTronix
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Nimbus II Infusion System recalled by InfuTronix | InfuTronix | Packaging Defects | Nationwide |
| Device | CLASS I | Nimbus Administration Set recalled by InfuTronix | InfuTronix | Packaging Defects | Nationwide |
| Device | CLASS II | Nimbus PainPro Ambulatory Infusion Pumps recalled by InfuTronix | InfuTronix | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |