Richard Wolf GmbH Recall 91953
Description: FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Richard Wolf GmbH Recall 91953 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1423-2023 |
| Event ID | 91953 |
| Event Description | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 |
| Product Type | Devices |
| 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), 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). |
| Quantity | 390 units |
| Recall Reason | 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. |
| Device Classification | 20230503 |
| Device Code Info | UDI/DI 04055207009635, Lot Numbers: 4500377840, 4500377840, 4500377840, 4500376297, 4500371970, 4500363663, 4500363098, 4500361404, 4500353562, 4500349168, 4500347747, 4500338560, 4500333999 |
| Center Classification Date | 20230424 |
| Recall Initiation Date | 20230324 |
| Recalling Firm | Richard Wolf GmbH |
| Initial Notification | Letter |
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