Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
FDA device recall Z-1759-2019 · posted 2019-06-19 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
- Action taken
- Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. 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
- 3483 units
- Distribution
- Worldwide - US Nationwide Distribution
- Date initiated
- 2019-05-24
- Date posted
- 2019-06-19
- 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 |