Z-1424-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- March 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 319 units
Product Description
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
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 Pattern
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).
Code Information
UDI/DI: 04055207020265; Lot Numbers: 4500377618, 4500377296, 4500374239, 4500371819, 4500367415, 4500363102, 4500367414, 4500363666, 4500363102, 4500359744, 4500357831, 4500354319, 4500352415, 4500349678, 4500344619, 4500347121, 4500349678, 4500348605, 4500344619, 4500347121, 4500344619, 4500341300, 4500338554, 4500337773, 4500335110