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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Action INDUSTRIES INC., General Purpose Instrument Tray

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 Class 2 Device Recall Medical Action INDUSTRIES INC., General Purpose Instrument Traysee related information
Date Initiated by FirmMay 11, 2021
Create DateJune 24, 2021
Recall Status1 Terminated 3 on May 10, 2023
Recall NumberZ-1948-2021
Recall Event ID 87954
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductMedical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
Code Information Batch Numbers: 0000277610, Exp. 04/15/2022; 0000276879, Exp. 04/15/2022
Recalling Firm/
Manufacturer
Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer 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
FDA Determined
Cause 2
Process control
ActionMedical 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 Commerce102 cases of 20 units
DistributionUS Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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