Medrad Hand Controller Sheath Recalled for Potential Sterility Breach
Medrad Inc is recalling Hand Controller Sheaths because a missing seal may compromise sterility. The product is used in cardiac catheterization procedures.
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: The recall involves a medical device where a sterility breach poses a risk of harm (infection) to patients, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Medrad Inc is recalling the MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, due to a potential breach of sterility. The seal between the white polyethylene and the clear plastic on the package may be missing, which could allow contamination of the accessory.
This sterile sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller during cardiac catheterization procedures, helping to prevent cross-contamination between patients. The recall covers 832,175 units distributed worldwide, including nationwide in the USA.
Healthcare facilities and users should check their inventory for the affected lot numbers listed in the recall notice. If the seal is missing, the product should not be used. Users should contact Medrad Inc for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination b
- Manufacturer
- Medrad Inc
- Affected units
- 832,175
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 (20)
- Catalog number AVA 500 HCS/3010903 - Lot numbers D72211
- DA82711
- DA93131
- D101091
- D101681
- D110591
- D111961
- D113341A
- D120731
- D101641
- D82741
- D93131
- DA101091
- DA101691
- D110601
- D111991
- D113351
- D120831A
- D72251
- D83011
Distribution
Distributed nationwide across the United States.
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