United StatesMedtronic Perfusion Systems is recalling Octopus Evolution Tissue Stabilizer Model TS2000, Octopus Evolution AS Tissue Stabilizer Model TS2500, and Octopus 4 Tissue Stabilizer Model 29400, identified by the listed UDI-DIs and serial numbers. The recall was issued after staff found an assembly error where the short tube was attached to the bottom of the canister and the long tube to the top, contrary to the intended design.
What's being recalled
Octopus Evolution Tissue Stabilizer, Model TS2000
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Octopus 4 Tissue Stabilizer, Model 29400
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN, United States.
How to identify it
UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115 UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199 UDI-DI: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
The hazard
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)