QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Summary
The FDA issued a Class II for QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used by Wilson-Cook Medical Inc.. Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment ar.
Details
Source
Device Recall
External ID
Z-0458-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Lot/Code Info: UDI/DI 00827002227675 (each), 10827002227672 (case), Lot Numbers: W4739833, W4749234, W4750262, W4756463, W4756465, W4720843, W4722160, W4722641, W4723307, W4724321, W4739835, W4740109, W4740421, W4746519, W4747434, W4748249, W4749510, W4749744, W4750867, W4751104, W4751904, W4752276, W4752565, W4752902, W4752908, W4755364, W4756899, W4757275, W4758645, W4759509, W4760713, W4761742, W4761743
Quantity Affected: 111 devices
Reason for Recall
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Distribution
US
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-03
Company
Winston Salem, NC
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 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 clearances.
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 (Wilson-Cook Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wilson-Cook Medical Inc. have FDA actions?
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0458-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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