The Recall Desk
HighFDA (Devices)·Z-1947-2021·Announced 2021-06-30

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.

What this means for you

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
Category
Medical Device — Surgical Instruments
Hazard
  • metal-flaking
  • foreign-body

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

Distributed nationwide across the United States.

Related recalls

Same category