Wilson-Cook Teslatome Bipolar Sphincterotomes recalled for electrical current hazard
Wilson-Cook Medical is recalling certain Teslatome Bipolar Sphincterotomes (medical devices used during endoscopic procedures) because some units may contain a manufacturing defect—a void in the material that separates internal channels. This defect can cause electrical current to flow incorrectly during the cutting procedure.
From the FDA notice · Read the official notice ↗ · All Wilson-Cook recalls
What to do
- If your facility uses Teslatome Sphincterotomes (Model G60784 or G60785), stop using affected units immediately.
- Check the work order numbers on your devices against the recall list to confirm if you have affected units.
- Contact Wilson-Cook Medical or your device supplier for instructions on return or replacement.
- Review patient records for any recent procedures using these devices and follow up as advised by your physician.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- U.S. Distribution to states of: CA, CO, IN, and NC.
- Made for
- All ages (0 months and older)
Details
- Units affected
- 153
- Illnesses reported
- None reported
- Manufactured in
- 4900 Bethania Station Rd, Winston Salem, NC, United States
- Classification
- Class II
- Recall number
- Z-1362-2026
In the FDA's words
- Description
- 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. 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. 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 Distribution: U.S. Distribution to states of: CA, CO, IN, and NC. Affected quantity: 153
- 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.
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