AVID Medical recalled 228 units of the Halyard CPT BASIC IR Pack on August 4, 2025. The recall follows reports of open header bag seals that may compromise sterility. Healthcare providers and patients should stop using the device immediately.
Potential for open header bag seals, compromising sterility.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AVID Medical, Inc. or your healthcare provider for instructions. Notification method: E-Mail
The recalled product is the Halyard CPT BASIC IR Pack, Model Number 1646381, with a UDI of 10809160363256. It has a lot number of 1646381 and an expiration date of January 31, 2028. The product was distributed nationwide, specifically in Florida.
The recall stems from a potential risk of open header bag seals. This issue may compromise the sterility of the medical device, posing a high risk to patients.
No specific incidents or injuries have been reported related to this recall. The potential risk remains significant due to the compromised sterility.
Stop using the Halyard CPT BASIC IR Pack immediately. Follow the manufacturer's instructions for returning the product and contact AVID Medical, Inc. or your healthcare provider for further guidance.
For more information, contact AVID Medical, Inc. via email as per the recall notification. Additional details can be found on the FDA website.
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