United StatesTeslatome Bipolar Sphincterotomes (REF TESLA-B2535-260, Model G60784, UDI-DI 00827002607842 and REF TESLA-B2535-450, Model G60785, UDI-DI 00827002607859), used for ductal cannulation and sphincterotomy (and to bridge strictures when preloaded), are being recalled. They may contain a void in the material separating the wire guide and cutting wire lumens, which can cause an inappropriate path of current during cutting.
What's being recalled
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
Recalling firm: Wilson-Cook Medical Inc., Winston Salem, NC, United States.
How to identify it
RPN: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 Work Order Number / RPN W4954835 / TESLA-B2535-260 W4954836 / TESLA-B2535-260 W4957208 / TESLA-B2535-260 W4958992 / TESLA-B2535-260 W4960895 / TESLA-B2535-260 W4960896 / TESLA-B2535-260 W4961670 / TESLA-B2535-260 W4965708 / TESLA-B2535-260 W4966040 / TESLA-B2535-260 W4966803 / TESLA-B2535-260 W4967866 / TESLA-B2535-260 W4968515 / TESLA-B2535-260 W4968867 / TESLA-B2535-260 W4969292 / TESLA-B2535-260 W4969674 / TESLA-B2535-260 W4969687 / TESLA-B2535-260 W4970315 / TESLA-B2535-260 W4970662 / TESLA-B2535-260 W4971561 / TESLA-B2535-260 W4972693 / TESLA-B2535-260 W4973085 / TESLA-B2535-260 W4974435 / TESLA-B2535-260 W4974588 / TESLA-B2535-260 W4975407 / TESLA-B2535-260 W4975688 / TESLA-B2535-260 W4977514 / TESLA-B2535-260 W4977824 / TESLA-B2535-260 W4979182 / TESLA-B2535-260 W4979183 / TESLA-B2535-260 W4979665 / TESLA-B2535-260 W4982425 / TESLA-B2535-260 W4982436 / TESLA-B2535-260 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 Work Order Number / RPN: W4962311 / TESLA-B2535-450 W4966039 / TESLA-B2535-450 W4968222 / TESLA-B2535-450 W4969306 / TESLA-B2535-450 W4970322 / TESLA-B2535-450 W4971499 / TESLA-B2535-450 W4975687 / TESLA-B2535-450 W4977254 / TESLA-B2535-450 W4982013 / TESLA-B2535-450
The hazard
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
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
U.S. Distribution to states of: CA, CO, IN, and NC.
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)