Absorbable Surgical Tacks Recalled for Potential Sterility Compromise
Covidien LP is recalling AbsorbaTack Absorbable Fixation Device 30 due to packaging defects that may compromise product sterility. Fifty-four units were distributed in five states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall. The hazard is theoretical with no reported illnesses or injuries. However, potential sterility compromise in a surgical device represents a risk-of-harm product. Per the rubric, when no illnesses have been reported and the hazard is theoretical, the score is at most 3.
Plain-English summary
Covidien LP is recalling the AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks (5 mm, Model ABSTACK30). This device is intended for fixation of prosthetic material to soft tissue during minimally invasive and open surgical hernia repair procedures.
The recall is due to a packaging defect in the foil pouch. The side seal may have low seal strength, potentially resulting in a breach of the sterile and moisture barrier that protects the device, and compromising the product's sterility.
Fifty-four units have been distributed nationwide in California, Colorado, Florida, Illinois, and Texas under lot number N3J1860Y. Healthcare facilities that received this product should contact Covidien LP for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Covidien LP
- Hazard
- sterility-compromise
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN 20884523006527 Lot number: N3J1860Y
Distribution
Distributed nationwide across the United States.
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