Z-1933-2018 Class II Terminated
FDA device recall Z-1933-2018 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: 220608 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
- 220608 units
Product Description
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F 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: 67016114501 67016114502 67016114503 67016124502 67016124503 67016124504 67017014501 67017024501 67017024502 67017024503 67017024504 67017034501 67017034503 67017044503 67017044504 67017044505 67017054501 67017054502 67017054503 67017054504 67017064501 67017064502 67017064503 67017064504 67017074501 67017074502 67017084501 67017084502 67017104501
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1933-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026