Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d
FDA device recall Z-2312-2019 · posted 2019-09-09 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 1805730 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2019-07-30
- Date posted
- 2019-09-09
- Date terminated
- 2022-02-15
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHERIDAN/HVT,CF, UNCUFFED (K822082) | Sheridan Catheter Corp. | 1982-08-10 |