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
Reported: February 14, 2024 Initiated: November 16, 2023 #Z-0986-2024
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
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
Details
- Recalling Firm
- Covidien LP
- Units Affected
- 54 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, IL, TX.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Covidien LP. Units affected: 54 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0986-2024.
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