FDA-Device2023-05-03Class II

FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685

Richard Wolf GmbH

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.

Sold states

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), Kuwait (KW), Kazakhstan (KZ), LB, Lithuania (LT), Marzocco (MA), Mexico (MX), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Pakistan (PK), Poland (PL), Palestine (PS), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudi Arabia (SA), Slovenia (SI), Slovakia (SK), Thailand (TH), Turkey (TR).

Affected count

319 units

Manufactured in

Pforzheimer Str. 32, N/A, Knittlingen, N/A, Germany

Products

FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1424-2023

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