DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Reported: June 16, 2021 Initiated: April 9, 2021 #Z-1787-2021
Product Description
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Reason for Recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Details
- Recalling Firm
- Avid Medical, Inc.
- Units Affected
- 560 kits
- Distribution
- Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
- Location
- Toano, VA
Frequently Asked Questions
What product was recalled? ▼
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.. Recalled by Avid Medical, Inc.. Units affected: 560 kits.
Why was this product recalled? ▼
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Critical. Recall number: Z-1787-2021.
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