FDA recall Z-0010-2025

Smiths Medical ASD Inc. · Class II · device

Product

CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-06-26
Report date
2024-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2025