CLASS I Device recall · Reported 18 Sep 2019 · FDA Enforcement Report
Sheridan/CF Novaplus recalled by Teleflex Medical
Teleflex Medical is recalling Sheridan/CF Novaplus, distributed nationwide in the US. The recall was initiated on 30 Jul 2019 and the FDA has classified it as Class I.
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-2317-2019
- FDA event ID
- 83461
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Jul 2019
- FDA classified
- 9 Sep 2019
- Reported
- 18 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Jul 2019 | Recall initiated by company | |
| 9 Sep 2019 | Classified by FDA | +41 days |
| 18 Sep 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
Product as listed by the FDA
Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Sheridan/CF Novaplus recalled?
Yes. Teleflex Medical recalled Sheridan/CF Novaplus on 30 Jul 2019. The recall is Class I and its status is Terminated. Recall number Z-2317-2019.
Why was it recalled?
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
Which lots are affected?
Batch numbers: 73K1600156 73K1600735 73L1600501 73A1700120 73B1700321 73C1700425 73D1700630 73E1700504 73G1700146 73H1700053 73J1700307 73K1700085 73B1800223 73B1800371 73C1800372 73D1800655 73E1800579 73G1800627 73H1800203 73H1800429 73H1800758 73J1800118 73J1800696
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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