FDA recall Z-1576-2022

Baxter Healthcare Corporation · Class II · device

Product

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100

Reason for recall

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Distribution

Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Key facts

Status
Ongoing
Initiation date
2022-07-22
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1576-2022