Recalls / —
—#164223
Product
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.
- FDA product code
- GAB — Needle, Suturing, Disposable
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lot Numbers: 67016114502 67016124502 67017014501 67017024502 67017064502 67017064503 67017074501 67017074502 67017084502 67017084503 67017104501
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 #164223. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.