Device product
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
Z-2922-2020
Product summary
- Event
- Event 86200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 eaches
- Official record key
device-enforcement:Z-2922-2020
Official wording
Reason: Potential sterility issue
Code information: 74K1900074 74K1901335 74L1901435 74M1900809
Distribution pattern: US Distribution of states to: AR AZ CA CO FL GA IA IL IN LA MI MN MS NC NH NV NY OH OK OR PA SD TN TX VA WA WI
Derived failure modes
-
Unknown
Potential sterility issue