Terumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks
Terumo is recalling 2,677 Cardiovascular Procedure Kits containing Pall LG6NS filters due to a risk of blood leaks through the hydrophobic portion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or structural defects in medical devices are rated as Severe (4).
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 2,677 units of Terumo Cardiovascular Procedure Kits that contain Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. The recall is due to a potential defect where blood may leak through the hydrophobic portion of the filters.
These kits are sterile, disposable devices intended for one-time use in extracorporeal circuits during cardiopulmonary bypass procedures. The filters are designed to reduce circulating leukocytes and exclude microemboli greater than 40 microns in size from the perfusate. The affected units were distributed in the United States to the states of Alabama, Ohio, Virginia, North Carolina, Georgia, New York, and Florida.
The recall is classified as Class II by the FDA. Healthcare providers and patients should stop using the affected kits and contact Terumo Cardiovascular Systems Corp for further instructions.
The recalled product
- Product
- Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use…
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- Affected units
- 2,677
Distribution
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