FDA Medical Device Recalls (openFDA)
Teleflex Medical: Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
- Recall number
- Z-2317-2019
- Recalling firm
- Teleflex Medical
- Product
- Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
- Status
- Terminated
- Initiated
- 2019-07-30
- Posted
- 2019-09-09
- Terminated
- 2022-02-15
- Reason
- 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
- 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
- 77136 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- K822082
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 3005747797
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28