Z-0089-2016 Class II Terminated
FDA device recall Z-0089-2016 was initiated by Resource Optimization & Innovation Llc on Apr 22, 2015 and is designated Class II. Reason for recall: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. The recall status is terminated (terminated Mar 28, 2017). Affected quantity: 1,400 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2015
- Initiation Date
- Apr 22, 2015
- Termination Date
- Mar 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,400 kits
Product Description
regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Reason for Recall
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Distribution Pattern
Distribution was made to LA, MS, and TX.
Code Information
Lot numbers 18235, 19608, 20169, 20976, 21911, and 23947.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0089-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026