FDA-Device2018-06-06Class II
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS 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
Medline Industries Inc
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
Affected count
2600 units
Manufactured in
Three Lakes Drive, N/A, Northfield, IL, United States
Products
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1936-2018Don't want to check this manually?
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