Dialysis access kits recalled for potential fungal contamination risk
Avid Medical is recalling medical dialysis access kits due to potential fungal growth in an applicator component that may compromise the package seal and contaminate other components. Approximately 560 kits distributed nationwide are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. The recall involves risk of fungal contamination and package integrity breach in a medical device used for dialysis access, a critical medical procedure.
Plain-English summary
Avid Medical, Inc. is recalling the DIALYSIS ACCESS Medical convenience kit (Part Number VMED004-03). Approximately 560 kits were distributed nationwide to medical facilities in Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee.
The kits are being recalled due to potential package integrity issues. The BD ChloraPrep 3mL applicator component included in the kit may develop a fungal growth (Aspergillus penicillioides) under certain circumstances. This fungal growth could breach the package's protective barrier and potentially contaminate other components in the kit.
Facilities and individuals who received these kits should stop using them immediately. The affected lot numbers are: 1409970 (expires 04/26/2022), 1412734 (expires 10/01/2021), 1413146 (expires 10/01/2021), and 1413395 (expires 04/25/2022). Contact Avid Medical, Inc. for instructions on returning affected units or receiving replacements.
The recalled product
- Product
- DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Dialysis Access
- Affected units
- 560
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 (6)
- Part Number:VMED004-03
- Package GTIN: 20809160238247
- Lot Number: 1409970 (Expiration Date: 04/26/2022)
- 1412734 (Expiration Date: 10/01/2021)
- 1413146 (Expiration Date: 10/01/2021)
- and 1413395 (Expiration Date: 04/25/2022)
Distribution
Part of a larger recall action
This product is one of 4 recalled by Avid Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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