Device 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.
Z-0120-2019
Product summary
- Firm
- A M Systems Inc
- Event
- Event 81076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 610
- Official record key
device-enforcement:Z-0120-2019
Official wording
Reason: Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
Code information: Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567
Distribution pattern: US Distribution to states of: OH, PA, and NC.
Derived failure modes
-
Unknown
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.