Recall Z-0120-2019— A M Systems Inc
Class II · Terminated
Class II FDA medical device recall by A M Systems Inc, initiated 2018-08-10, terminated 2021-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Some of the Disposable Smooth Interior Tubing may pull apart when stretched..
- Recalling firm
- A M Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-10
- Terminated
- 2021-05-13
- Firm location
- Sequim, WA, United States
Product description
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.
Reason for recall
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
Data sourced from openFDA. This site is unofficial and independent of the FDA.