AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material t
Summary
The FDA issued a Class II for AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intend by Covidien LP. Reason: Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, c.
Details
Source
Device Recall
External ID
Z-0986-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
Lot/Code Info: GTIN 20884523006527 Lot number: N3J1860Y
Quantity Affected: 54 units
Reason for Recall
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
Distribution
US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-16
Company
Mansfield, MA
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 274 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien LP has 89 FDA actions in our database, including 89 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 (Covidien LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien LP have FDA actions?
Covidien LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0986-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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