Adult Chest Tube Tray Recalled Due to Package Integrity Risk
Avid Medical is recalling 130 Adult Chest Tube Trays due to potential contamination from mold growth in a component. The BD ChloraPrep applicator may grow Aspergillus penicillioides, which could breach package integrity and contaminate other kit 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 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 recall. Per the severity rubric, FDA Class I recalls are scored at severity 4 (Severe) or higher. Since no deaths, serious injuries, or hospitalizations have been reported, this scores at 4 rather than 5.
Plain-English summary
Avid Medical, Inc. is recalling 130 Adult Chest Tube Trays (Part Number LAKC001-04) distributed nationwide.
The recall was initiated due to a potential breach in package integrity of the BD ChloraPrep 3mL applicator component included in these kits. Under certain circumstances, the applicator may grow Aspergillus penicillioides, a fungal organism. A breach in package integrity could contaminate other components within the medical kit.
Affected kits include lot numbers 1404809, 1408337, 1427628, 1427629, 1432814, and 1436046, with expiration dates ranging from August 2021 to November 2021. The kits were distributed to healthcare facilities in Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee.
The recalled product
- Product
- ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 130
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 (8)
- Part Number: LAKC001-04
- Package GTIN: 20809160261016
- Package GTIN: 20809160293130
- Lot Number: 1427628 (Expiration Date: 09/01/2021) Part Number: LAKC001-04
- Package GTIN: 20809160313005
- Lot number: 1427629 (Expiration Date: 09/01/2021)
- 1432814 (Expiration Date: 11/30/2021)
- and 1436046 (Expiration Date: 11/30/2021)
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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