AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.
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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This is an ENT procedure convenience kit used by healthcare providers. It is intended for sterile use.
Open header bag seals can compromise sterility, increasing infection risk when used in procedures in which sterility is required.
This recall is not described as part of a broader industry pattern.
Immediate stop-use is required. No injuries reported yet, but sterility loss poses significant infection risk.
Recall notices and FDA enforcement report Z-2530-2025 provide identifiers.
Remedy process to be announced by AVID Medical; refunds or replacements likely within weeks to months.
Keep copy of recall notice, purchase records, batch/UDI, and correspondence with AVID Medical
Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218. Distribution: US Nationwide, in Florida. Quantity: 57 units. Brand: AVID Medical.
No injuries or incidents have been reported.
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