Avid Medical Fistula On-Off Kit Recalled for Potential Fungal Contamination
Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.
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: This product received an FDA Class I designation, which under recall classification rules establishes a minimum score of 4 (Severe). Although the hazard is theoretical with no reported illnesses or injuries, Class I medical device recalls mandate a Severe minimum rating.
Plain-English summary
Avid Medical, Inc. is recalling 720 Fistula On-Off Kits (Part Number MMTN020, Lot Number 1351695 with expiration date 10/31/2021). These medical convenience kits contain a BD ChloraPrep 3mL applicator component.
The recall was issued because the applicator component may grow Aspergillus penicillioides under certain circumstances. If fungal growth occurs, it can breach the applicator's package integrity and potentially contaminate other components in the kit.
The affected kits were distributed nationwide to Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee.
This is an FDA Class I recall, the agency's most serious classification for medical devices.
The recalled product
- Product
- FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
- Manufacturer
- Avid Medical, Inc.
- Hazard
- fungal-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 (3)
- Part Number: MMTN020
- Package GTIN: 20809160223489
- Lot Number: 1351695 (Expiration Date: 10/31/2021)
Distribution
Distributed nationwide across the United States.
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