Recall Z-0120-2019 ยท BYX Tubing, Pressure And Accessories
A M Systems Inc
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
| Date | Aug 10, 2018 |
| Status | Terminated |
| Reason | Some of the Disposable Smooth Interior Tubing may pull apart when stretched. |
| Root cause | Process control |
| Action | On 08/10/2018, the firm, A-M Systems, sent an "URGENT: Notification of Product Recall/Correction" letter to customers via email informing them that it was determined that some of the Disposable Smooth Interior Tubing may pull apart when stretched. Customers were advised to provide the firm with the number of items distributed from the affected lots and the number of items still remaining in their inventory from these lots so that the firm could accurately track the status of this correction action. The customers are instructed to please use the enclosed form and self-addressed envelope to ret |
| Quantity | 610 |
| Distribution | US Distribution to states of: OH, PA, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.