Sequim, WA, United States
A M Systems Inc recalls
1 recall recorded since 2018, most recently on 10 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 August 2018
- Terminated
- 13 May 2021
- Reason
- Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
- Distribution
- US Distribution to states of: OH, PA, and NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0120-2019
- 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 interconn
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.