Z-0120-2019 Class II Terminated
FDA device recall Z-0120-2019 was initiated by A M Systems Inc on August 10, 2018 and is designated Class II. Reason for recall: Some of the Disposable Smooth Interior Tubing may pull apart when stretched. The recall status is terminated (terminated May 13, 2021). Affected quantity: 610.
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- August 10, 2018
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 610
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.
Distribution Pattern
US Distribution to states of: OH, PA, and NC.
Code Information
Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567