Z-1947-2021Class II

novaplus, General Purpose Kit, Cat. No. 56603

Name: Z-1947-2021 novaplus, General Purpose Kit, Cat. No. 56603
Creator: Medical Action Industries, Inc. 306
Published: 2021-05-11
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2021-05-11 / Terminated / root cause: manufacturing process

FDA source

Medical Action Industries, Inc. 306 began a recall of novaplus, General Purpose Kit, Cat. No. 56603 on 2021-05-11. FDA classified it as Class II and gives the reason as "There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1947-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-11
Posted: 2021-06-24
Terminated: 2023-05-10
Recalling firm: Medical Action Industries, Inc. 306
Product: novaplus, General Purpose Kit, Cat. No. 56603
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medical Action Industries, Inc. initiated the recall by email on 05/11/2021 Distributors were instructed to notify their customers. The firm is requesting those in possession of the recalled articles discard them.
Quantity in commerce: 21 cases of 20 units
Distribution: US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
Product codes and lots: Batch Numbers: 0000275724, Exp. 02/15/2022; 0000277619, Exp. 04/15/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24
Z-1946-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24
Z-1947-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24
Z-1948-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24
Z-1949-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)