Flex. Grasp. Forceps 5fr WL 550mm recall
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
Why was Flex. Grasp. Forceps 5fr WL 550mm recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
- Recalling firm
- Richard Wolf GmbH
- Quantity
- 319 units
- 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).
- Recall date
- May 3, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)