| Class 2 Device Recall Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat | |
Date Initiated by Firm | May 11, 2021 |
Create Date | June 24, 2021 |
Recall Status1 |
Terminated 3 on May 10, 2023 |
Recall Number | Z-1945-2021 |
Recall Event ID |
87954 |
Product Classification |
Instrument, surgical, disposable - Product Code KDC
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Product | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220 |
Code Information |
Batch Number 0000274502, Expiration Date 07/24/2025 |
Recalling Firm/ Manufacturer |
Medical Action Industries, Inc. 306 25 Heywood Rd Arden NC 28704-9302
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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 |
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 | 23 boxes of 20 devices |
Distribution | US 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 Cycle | TPLC Device Report |
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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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