Recall Z-1912-2019 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Teleflex Medical
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 s
| Date | Jul 15, 2019 (initiated May 10, 2019) |
| Status | Terminated |
| Reason | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit. |
| Root cause | Process control |
| Action | 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) numb |
| Quantity | 20 units |
| Distribution | US Nationwide Distribution in the states of AL, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173280 | Neonatal ConchaSmart Breathing Circuits Teleflexmedical, Inc., Aug 2, 2018 |