Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
This recall has been terminated (originally issued January 9, 2019).
- Company
- Karl Storz Endoscopy
- Recall Initiated
- January 9, 2019
- Terminated
- September 28, 2022
- Recall Number
- Z-1942-2020
- Quantity
- 543 boxes were distributed; 10 ea per box.
- Firm Location
- El Segundo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Distribution
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
Lot / Code Info
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
Root Cause
Vendor change control
Action Taken
The recalling firm sent an URGENT SAFETY NOTICE OF PRODUCT RECALL (via FedEx) to the impacted customers on 01/09/20120, along with acknowledgement confirmation for customer to sign and return it to the firm.
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