FDA recall Z-2759-2017

Smiths Medical ASD Inc. · Class II · device

Product

Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.

Reason for recall

The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.

Distribution

Canada only

Key facts

Status
Terminated
Initiation date
2016-12-09
Report date
2017-08-02
Termination date
2017-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2759-2017