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Class 2 Device Recall Medical Action INDUSTRIES INC., Minor Procedure Tray |
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| Date Initiated by Firm |
May 11, 2021 |
| Create Date |
June 24, 2021 |
| Recall Status1 |
Terminated 3 on May 10, 2023 |
| Recall Number |
Z-1949-2021 |
| Recall Event ID |
87954 |
| Product Classification |
General surgery tray - Product Code LRO
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| Product |
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 |
| Code Information |
Batch Numbers: 0000275137, Exp. 05/29/2022; 0000276914, Exp. 02/01/2023 |
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
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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 |
31 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. |
| 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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