Device product
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
Z-1148-2021
Product summary
- Event
- Event 87231
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 units
- Official record key
device-enforcement:Z-1148-2021
Official wording
Reason: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Code information: Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK
Distribution pattern: US Nationwide distribution in the states of FL and OH.
Derived failure modes
-
Unknown
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.