Date Initiated by Firm | April 24, 2018 |
Create Date | May 25, 2018 |
Recall Status1 |
Terminated 3 on August 04, 2020 |
Recall Number | Z-1934-2018 |
Recall Event ID |
80017 |
Product Classification |
Needle, suturing, disposable - Product Code GAB
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Product | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR
Product Usage:
A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. |
Code Information |
Lot Numbers: 67016114502 67016124501 67016124502 67016124507 67017014501 67017024502 67017034501 67017034503 67017064502 67017074502 67017084502 67017084503 67017094501 67017094503 67017094505 67017104501 67017114501 67017114502 |
Recalling Firm/ Manufacturer |
Medline Industries Inc Three Lakes Drive Northfield IL 60093
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For Additional Information Contact | Kassandra Cotner 866-359-1704 |
Manufacturer Reason for Recall | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters. |
FDA Determined Cause 2 | Package design/selection |
Action | Medline sent an Urgent Recall letter dated April 24, 2018. The letter identified the affected product, problem and actions to be taken. Customer were instructed to check inventory, quarantine all affected product and return completed enclosed response form. Those consignees who further distributed the product were directed to notify their customers. For question contact 866-359-1704. |
Quantity in Commerce | 80200 units |
Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates |
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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