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FDA (Device enforcement)Recalled 2023-03-24class ii

Richard Wolf GmbH: FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

Hazard

Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.

Details from the source

Reason for recall: Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope. Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates (AE), Argentina (AR), Austria (AT), Belgium (BE), BO, Brazil (BR), Canada (CA), Chile (CL), Czech Republic (CZ), Germany (DE), Denmark (DK), Ecuador (EC), Spain (ES), Finland (FI), France (FR), Greece (GR), Hong Kong (HK), Croatia (HR), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), South Korea (KR), K Quantity: 838 units Lot/code info: UDI/DI: 04055207009574; Lot Numbers: 4500377299, 4500377299, 4500371834, 4500374645, 4500369724, 4500367397, 4500363662, 4500363096, 4500359201, 4500356582, 4500353558, 4500350415, 4500347760, 4500345769, 4500341314, 4500341314, 4500338447, 4500336245, 4500334737, 4500334002

UPC codes

04055207009574

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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