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FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 recallZ-1424-2023 · Richard Wolf GmbH · initiated Mar 24, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Richard Wolf GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm issued an Urgent Medical Device Correction notice on 03/24/2023 to its consignees by USPS certified mail. The notice explained the issue and explained the proper use of the device to avoid exposing patients to improper handling. Richard Wolf is already optimizing the forceps design. Further batches of these forceps can be used with the expected maximum flexibility. The procedure described in the notice does not expose patients to risks from jaw sections that do not open. The firm issued a follow up letter titled, Urgent Medical Device Removal beginning on 08/02/2023, via USPS certified mail. The notice advised customers that the device has been redesigned. Customers were instructed to review inventory, ensure all users are informed of the recall, notify customers if further distributed, return the customer response form, arrange for the shipment of revised forceps and return affected devices. The firm issued an updated letter to customers who have not yet responded to the original notification on about 09/12/2023. The updated letter included an image of where to locate the lot/batch number on the forceps, and the table of lot/batch numbers was also reorganized for better readability.

Recall details

Recall number
Z-1424-2023
Status
Open, Classified
Initiated by the company
Mar 24, 2023
Posted by the FDA
Apr 24, 2023
Recalling firm
Richard Wolf GmbH
Quantity
319 units
Product code
FCL
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).

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91953).

Sources and updates

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