FDA recall Z-0175-2023

Baxter Healthcare Corporation · Class II · device

Product

Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table

Reason for recall

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Distribution

MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Key facts

Status
Ongoing
Initiation date
2022-09-20
Report date
2022-11-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0175-2023