Device product
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Z-1942-2020
Product summary
- Event
- Event 85388
- Status
- Terminated
- Classification
- Class III
- Quantity
- 543 boxes were distributed; 10 ea per box.
- Official record key
device-enforcement:Z-1942-2020
Official wording
Reason: The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Code information: Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555
Distribution pattern: 57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI
Derived failure modes
-
Unknown
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.