Merit Medical Systems Aspira Kits Recalled Due to Temperature Excursions
Merit Medical Systems Aspira Dressing and Drainage Kits recalled due to facility temperature excursions from June to August 2021. Exposure to higher temperatures may have reduced product effectiveness; no illnesses reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—temperature exposure may have affected product effectiveness, but no actual failures or harm have been documented.
Plain-English summary
Merit Medical Systems Aspira Dressing Kit (Model 4991503) and Aspira Pleural/Peritoneal Drainage Kit (Model 4992301) have been recalled. The affected products were distributed nationwide in the United States.
Between June 2021 and August 2021, the facility holding these products experienced temperature excursions before delivery. Exposure to higher temperatures may have impacted the effectiveness of the products. The recall affects all product lots received between June 1, 2021 and September 30, 2021. A total of 123 Dressing Kits and 407 Drainage Kits are involved in this recall.
No illnesses or injuries have been reported in connection with these products. Consumers who possess these recalled items should contact the manufacturer for guidance.
The recalled product
- Product
- a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Drainage Kits
- Hazard
- temperature-excursion
- reduced-effectiveness
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 (11)
- GTIN: a. 00884450394984 (EA)
- 00801741045011 (EA)
- 10801741045018 (CA)
- 10884450394981 (CA)
- 20801741045015 (BX)
- 20884450394988 (BX). b. 00801741045035 (EA)
- 00884450394861 (EA)
- 10801741045032 (CA)
- 10884450394868 (CA)
- 20801741045039 (BX)
- 20884450394865 (BX)
Distribution
Distributed nationwide across the United States.
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