Product Wiki · Recalls · U.S. FDA — Device Enforcement

MEDLINE O.R — recall Z-1936-2018

U.S. FDA — Device Enforcement · United States · 2018-04-24 · Class II

As described by U.S. FDA — Device Enforcement: 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 - O

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1936-2018
Date of alert
2018-04-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medline Industries Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.