FDA recall Z-1942-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-01-09

Report date

2020-05-20

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1942-2020