According to the FDA, a Class I recall has been issued for Teleflex’s Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column.
The recall was initiated due to complaints of cracks being observed, prior to use, on swivel wye adaptors, a part of the device, the FDA reports. Cracks in the adapter may cause breathing distress because the gas may leak and not reach the patient, according to the FDA, which added, breathing distress from insufficient oxygenation could result in serious adverse health consequences including death.
No injuries or deaths have been reported, the FDA said.
The FDA reports Teleflex received two complaints about cracks in the adaptor and 30% of adaptors are expected to exhibit cracks.
Recalled Product info:
- NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column
- Product Codes: 870-07KIT, 870-09KIT
- Lot Numbers: 74L1802044, 74L1802045
- Manufacturing Dates: November 2018
- Distribution Dates: December 2018 to January 2019
- Devices Recalled in the US: 300
- Date Initiated by Firm: May 10, 2019
Who May be Affected
- Hospitals and healthcare professionals using the Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column.
- Patients who may receive breathing support from the Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column.
On May 10 2019, Teleflex sent customers an Urgent Medical Device Recall letter. The letter instructed customers to:
- Immediately discontinue use and quarantine any affected products in inventory.
- Complete the enclosed Acknowledgement Form indicating whether you do or do not have stock of affected product. Fax the form to 1-855-419-8507 or email to firstname.lastname@example.org.
Customers who have questions or need additional assistance regarding this recall should contact Teleflex’s customer service by phone at 1-866-396-2111.