United StatesOlympus Corporation of the Americas is recalling CleverCut single-use sphincterotomes (including models such as KD-V411M-0320, KD-VC431Q-0720, KD-431Q-0720 and many other KD‑V/VC series catalog numbers and lots with valid expiration dates) used with an Olympus endoscope and guidewire for papillotomy. The recall was issued because devices that did not undergo thermoforming could deform and lose performance.
What's being recalled
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
And 15 more products.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model/Catalog Number: KD-V411M-0320; Material REF: (1) N1089430, (2) N1089410, (3) N5411130; UDI-DI: (1) 04953170183973, (2) 04953170466274, (3) 04953170380556; All Lots with a valid expiration date Model/Catalog Number: KD-VC431Q-0720; Material REF: (1) N5391530, (2) N5391510, (3) N5777830; UDI-DI: (1) 04953170466427, (2) 04953170466427, (3) 04953170466427; All Lots with a valid expiration date Model/Catalog Number: KD-431Q-0720; Material REF: (1) 5859230, (2) N6221831, (3) N6221840; UDI-DI: (1) 04953170042362, (2) 04953170463778, (3) 04953170466564; All Lots with a valid expiration date Model/Catalog Number: KD-V411M-0330; Material REF: (1) N1089530, (2) N1089510, (3) N5411230; UDI-DI: (1) 04953170380563, (2) 04953170380563, (3) 04953170380563; All Lots with a valid expiration date Model/Catalog Number: KD-V411M-0720; Material REF: (1) N1089610, (2) N5411330; UDI-DI: (1) 04953170184017, (2) 04953170380570; All Lots with a valid expiration date Model/Catalog Number: KD-V411M-0725; Material REF: (1) N1089710, (2) N5411430; UDI-DI: (1) 04953170380587, (2) 04953170380587; All Lots with a valid expiration date Model/Catalog Number: KD-V411M-0730; Material REF: (1) N1089810, (2) N5411530; UDI-DI: (1) 04953170380594, (2) 04953170380594; All Lots with a valid expiration date Model/Catalog Number: KD-V431M-0720; Material REF: (1) N1090410, (2) N1090430, (3) N5411930; UDI-DI: (1) 04953170184178, (2) 04953170184178, (3) 04953170184178; All Lots with a valid expiration date Model/Catalog Number: KD-V431M-0730; Material REF: (1) N1090530, (2) N1090510, (3) N5412030; UDI-DI: (1) 04953170380648, (2) 04953170380648, (3) 04953170380648; All Lots with a valid expiration date Model/Catalog Number: KD-VC431Q-0730; Material REF: (1) N5391610, (2) N5391630, (3) N5777930; UDI-DI: (1) 04953170466434, (2) 04953170466434, (3) 04953170466434; All Lots with a valid expiration date Model/Catalog Number: KD-VC411Q-0720; Material REF: (1) N5391210, (2) N5391230, (3) N5777530; UDI-DI: (1)…
The hazard
Devices which did not undergo thermoforming could deform and lose performance.
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 including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.
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)