FDA-Device2020-05-20Class III
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Karl Storz Endoscopy
Hazard
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Sold states
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
Affected count
543 boxes were distributed; 10 ea per box.
Manufactured in
2151 E Grand Ave, N/A, El Segundo, CA, United States
Products
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1942-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief