Karl Storz Endoscopy recalls Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
- Recall date
- January 9, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1942-2020
- FDA classification
- Class III
- Brand / firm
- Karl Storz Endoscopy
- Sold / distributed
- 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
Why it was recalled
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
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