Recall Z-2683-2016 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Teleflex Medical
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
| Date | Aug 29, 2016 (initiated Dec 3, 2015) |
| Status | Terminated |
| Reason | Cracking may occur at the 15mm and 22mm ISO female connector. |
| Root cause | Device Design |
| Action | INMED sent an Urgent - Field Safety Notice dated December 3, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to cease use and distribution of stock of the affected product batch and quarantine immediately. Customers are to return all affected product to MAQUET. An Acknowledgement form was included to be completed and returned to their MAQUET representative. If the product was distributed, they were instructed to provide the field safety notice to all of their customers who have received prod |
| Quantity | 2,700 units |
| Distribution | US Distribution to the states of : FL, KS, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.