Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0175-2023

September 20, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90848
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0175-2023

Official wording

Reason: 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.

Code information: a) UDI/DI 00615521003012, Serial Number 122190000035, Lot Number 122220000528 b) UDI/DI 00615521003036, Serial Number 122230000655, Lot Number 122180001460

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.