FDA recall Z-0166-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.

Reason for recall

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Distribution

US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.

Key facts

Status
Ongoing
Initiation date
2022-09-30
Report date
2022-11-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0166-2023