Z-1942-2020 Class III Terminated
FDA device recall Z-1942-2020 was initiated by Karl Storz Endoscopy on January 9, 2019 and is designated Class III. Reason for recall: The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level. The recall status is terminated (terminated September 28, 2022). Affected quantity: 543 boxes were distributed; 10 ea per box..
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- January 9, 2019
- Termination Date
- September 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 543 boxes were distributed; 10 ea per box.
Product Description
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Reason for Recall
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
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
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