FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Enforcement
- Recall Number
- Z-1422-2023
- Event ID
- 91953
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Richard Wolf GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 3, 2023
- Initiation Date
- March 24, 2023
- Classification Date
- April 24, 2023
- Address
- Pforzheimer Str. 32, N/A, Knittlingen, N/A, N/A, Germany
Description
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
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.
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
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).
838 units