Z-1935-2018 Class II Terminated
FDA device recall Z-1935-2018 was initiated by Medline Industries Inc on Apr 24, 2018 and is designated Class II. 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. The recall status is terminated (terminated Aug 4, 2020). Affected quantity: 23150 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 6, 2018
- Initiation Date
- Apr 24, 2018
- Termination Date
- Aug 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23150 units
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
Code Information
Lot Numbers: 67016114502 67017014501 67017024502 67017054501
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1935-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026