ENT surgical kit recalled for potential sterility compromise
AVID Medical is recalling Halyard ENT PACK convenience kits (Model JACK421-04) due to potential open header bag seals that could compromise product sterility. The recall affects 57 units distributed in Florida.
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 FDA medical device recall involving compromised sterility protection on surgical kits. The hazard is a risk-of-harm product where injury has not yet been reported. Per the rubric, risk-of-harm products without reported injury are scored as High.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ENT PACK convenience kits (Model JACK421-04, Lot Number 1647218, Expiration Date 7/17/2027) due to a potential defect affecting the sterility of the product.
The manufacturer identified that header bag seals on the product may open during handling or storage, potentially compromising the sterility of the surgical kit contents. The recall was initiated to prevent the distribution and use of kits with compromised sterility protection.
This recall affects 57 units that were distributed in the state of Florida. Facilities that have received affected units should contact AVID Medical, Inc. to arrange for return or replacement of the recalled kits.
No injuries or illnesses have been reported in connection with this defect.
The recalled product
- Product
- Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- sterility-compromise
- seal-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 (2)
- Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218
- Expiration Date: 7/17/2027.
Distribution
Distributed nationwide across the United States.
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