Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KI
FDA device recall Z-1912-2019 · posted 2019-07-15 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
- Action taken
- The firm initiated the recall by email on May 10, 2019. The recall notice requested the return of the product. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. For questions contact Customer Service at 1-866-396-2111.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BZE
- Quantity affected
- 20 units
- Distribution
- US Nationwide Distribution in the states of AL, TX
- Date initiated
- 2019-05-10
- Date posted
- 2019-07-15
- Date terminated
- 2024-04-22
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Neonatal ConchaSmart Breathing Circuits (K173280) | Teleflexmedical, Inc. | 2018-08-02 |