The Recall Desk
SevereFDA (Devices)·Z-1787-2021·Announced 2021-06-16

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
  • aspergillus-contamination
  • package-integrity-breach

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

Distributed nationwide across the United States.

Related recalls

Same category