Z-0229-2016 Class II Terminated
FDA device recall Z-0229-2016 was initiated by Resource Optimization & Innovation Llc on Aug 25, 2015 and is designated Class II. Reason for recall: The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set. The recall status is terminated (terminated Apr 6, 2017). Affected quantity: 255 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 11, 2015
- Initiation Date
- Aug 25, 2015
- Termination Date
- Apr 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 255 packs
Product Description
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Reason for Recall
The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
Distribution Pattern
Product was distributed to one customer in Oklahoma.
Code Information
Lot 25787E, exp. date 1/19/2017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0229-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026