AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.
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
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The CPT BASIC IR PACK is a sterile surgical or infection-control kit component used by healthcare providers during procedures.
A compromised header seal may allow contamination, leading to possible infection or ineffective sterility.
This recall is not identified as part of a broader industry pattern in the provided data.
Healthcare facilities may need to quarantine affected lots and reroute procedures to ensure sterility standards are met.
Inspect the packaging label for Model 1646381, UDI 10809160363256, and Lot 1646381.
AVID Medical will provide recall instructions and next steps; timelines are not specified here.
Keep all recall notices, packing labels, and supplier communications. Document lot numbers and UDI for each unit.
Brand: AVID Medical. Product: CPT BASIC IR PACK. Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Quantity: 228 units. Distribution: US nationwide with Florida. Recall date: 2025-08-04. Status: ACTIVE.
No injuries or incidents have been reported in the provided data.
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