Recall Z-1912-2019
Teleflex Medical · initiated May 10, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. These gases may be delivered by nasal prongs using the CareFusion Infant Flow system and the single limb circuit, or through bypassing upper airways, for example through the use of an endotracheal tube with the dual limb configuration.
Codes / lots: Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161
Reason for recall
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1912-2019
- Initiated
- May 10, 2019
- Posted by FDA
- July 15, 2019
- Terminated
- April 22, 2024
- Product code
- BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Quantity
- 20 units
- Distribution
- US Nationwide Distribution in the states of AL, TX
- Recalling firm
- Teleflex Medical, Morrisville, NC