—#164222

Product

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 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.

FDA product code: GAB — Needle, Suturing, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: 67016114502 67017014501 67017024502 67017054501

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

Timeline

Recall initiated: 2018-04-24
Terminated: 2020-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164222. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.