M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Summary
The FDA issued a Class II for M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and by New Wave Endo-Surgical, Corp.. Reason: The plastic housing on the device may fracture.
Details
Source
Device Recall
External ID
Z-1570-2023
Action Date
2023-05-17
Status
Terminated
Category
device
Product Description
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Lot/Code Info: UDI/DI: 00850009417022, Lot code C2020
Quantity Affected: 295 units
Reason for Recall
The plastic housing on the device may fracture
Distribution
US Nationwide distribution in the states of FL, MA, and GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-07-08
Company
Coconut Creek, FL
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 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (New Wave Endo-Surgical, Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New Wave Endo-Surgical, Corp. have FDA actions?
This is the only FDA action we have on record for New Wave Endo-Surgical, Corp. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1570-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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