Summary
The FDA issued a Class II for FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 by Richard Wolf GmbH. 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.
Details
Source
Device Recall
External ID
Z-1422-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
Product Description
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Lot/Code Info: 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
Quantity Affected: 838 units
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
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).
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-24
Company
Knittlingen, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Richard Wolf GmbH has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Richard Wolf GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Richard Wolf GmbH have FDA actions?
Richard Wolf GmbH has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1422-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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