Halyard CPT BASIC IR PACK Recalled for Potential Sterility Bag Seal Issues
AVID Medical is recalling 228 Halyard CPT BASIC IR PACK convenience kits (Model 1646381) due to potential for open header bag seals that could compromise sterility. The kits were 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 a sterility compromise risk. No illnesses or injuries have been reported. As a risk-of-harm medical device where injury has not yet been documented, this meets the rubric criterion for High severity.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CPT BASIC IR PACK (Model Number 1646381), a sterile convenience kit. The recall affects 228 units that were distributed in Florida.
The kits are being recalled because of a potential manufacturing defect: the header bag seals may open, which could compromise the sterility of the product. An opened seal could allow the contents to be exposed to contamination.
If you have stock of these kits with Lot Number 1646381 (UDI: 10809160363256, expiration date 1/31/2028), contact AVID Medical, Inc. for further instructions. Healthcare facilities should review their inventory and follow the manufacturer's guidance regarding affected units.
The recalled product
- Product
- Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device
- Hazard
- seal-defect
- contamination-risk
Distribution
Distributed nationwide across the United States.
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