Z-2317-2019Class I

Sheridan/CF Novaplus 7.0 mm, REF V5-10114

Name: Z-2317-2019 Sheridan/CF Novaplus 7.0 mm, REF V5-10114
Creator: Teleflex Medical
Published: 2019-07-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-07-30 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management on 2019-07-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2317-2019
Classification: Class I
Status: Terminated
Initiated: 2019-07-30
Posted: 2019-09-09
Terminated: 2022-02-15
Recalling firm: Teleflex Medical
Product: Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Product code: BTR Tube, Tracheal (W/Wo Connector)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated July 30, 2019 to affected customers. The letter explains the problem and requests the consignee discontinue use and quarantine of any of the recalled products then to notify Teleflex. The firm is requesting the return of the affected products. For questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 77136 units
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2317-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2311-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2312-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2313-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2314-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2315-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2316-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2317-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2318-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09

Product code BTR

K822082Class IISheridan/hvt,cf, UncuffedSheridan Catheter Corp. / cleared 1982-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)