United StatesZeiss Intrabeam Spherical Applicator 1.5 cm (REF 304534-6000-557, UDI (01)04049539101563, Batch A0002) — 13 units with serial numbers US: A63141, A63086; OUS: A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313 — is affected. The applicators were recalled because they failed to meet manufacturing specifications.
What's being recalled
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Recalling firm: Carl Zeiss Meditec AG, Oberkochen, N/A, Germany.
How to identify it
UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313
The hazard
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
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 in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
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)