novaplus General Purpose Kit hemostats recalled for potential metal flaking
Medical Action Industries is recalling novaplus General Purpose Kit (Cat. No. 56603) containing hemostats that may have flaking metal and brown spots on the instruments.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall affects surgical instruments where metal contamination poses a risk of harm in clinical applications. No illnesses or injuries have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, placing it at High severity.
Plain-English summary
Medical Action Industries, Inc. is recalling the novaplus General Purpose Kit (Catalog No. 56603) distributed nationwide due to a defect affecting hemostats included in the kit.
The recalled hemostats may have flaking metal and/or brown spots on the instrument surfaces. The recall involves 21 cases of 20 units each with batch numbers 0000275724 (expiration 02/15/2022) and 0000277619 (expiration 04/15/2022).
The product was distributed to facilities in Ohio, Colorado, California, Illinois, Florida, Virginia, Texas, Minnesota, Georgia, Washington, Massachusetts, Maryland, New York, Louisiana, Arizona, and Oregon.
The recalled product
- Product
- novaplus, General Purpose Kit, Cat. No. 56603
- Manufacturer
- Medical Action Industries, Inc. 306
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 (4)
- Batch Numbers: 0000275724
- Exp. 02/15/2022
- 0000277619
- Exp. 04/15/2022
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medical Action Industries, Inc. 306 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.
See all 5 products in this recall →Related recalls
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