Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical devic
Summary
The FDA issued a Class II for Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, by Carefusion 2200 Inc. Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the ma.
Details
Source
Device Recall
External ID
Z-2423-2023
Action Date
2023-08-23
Status
Ongoing
Category
device
Product Description
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Lot/Code Info: UDI/DI 10885403160592, Lot Number B23
Quantity Affected: 0 units
Reason for Recall
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Distribution
US and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-13
Company
Vernon Hills, IL
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 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Carefusion 2200 Inc has 80 FDA actions in our database, including 80 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 (Carefusion 2200 Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carefusion 2200 Inc have FDA actions?
Carefusion 2200 Inc has 80 FDA actions in our database, including 80 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2423-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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