Medical Convenience Kits Recalled Due to Mold Contamination Risk
Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified as FDA Class I, which the rubric defines as Critical (Score 5). FDA Class I designations indicate a reasonable probability of serious adverse health consequences or death due to the recalled product. The contamination of sterile medical device components with Aspergillus penicillioides poses a serious risk to patients.
Plain-English summary
Avid Medical, Inc. has recalled 160 FISTULA (ON/OFF) ALL IN ONE BAG medical convenience kits due to potential package integrity breach from fungal contamination in a component applicator.
The BD ChloraPrep 3mL applicator component included in these kits may grow Aspergillus penicillioides under certain circumstances. This fungal growth could breach the kit's package integrity and contaminate other sterile components within the kit.
The recalled kits were distributed to healthcare facilities in Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee. The affected lot numbers are 1445301 and 1445302, both expiring April 30, 2022.
If you have received these kits, discontinue use immediately and contact Avid Medical for return or disposal instructions.
The recalled product
- Product
- FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
- Manufacturer
- Avid Medical, Inc.
- Affected units
- 160
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 (2)
- Part Number:VAMK024-03
- Package GTIN: 20809160342500
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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