AbsorbaTack Absorbable Fixation Device 30 Violet recall: Sterility Concern
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally…
Why was AbsorbaTack Absorbable Fixation Device 30 Violet recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 20884523006527 Lot number: N3J1860Y
- Product
- AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally…
- Recalling firm
- Covidien LP
- Quantity
- 54 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, IL, TX.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)