FDA Device recall Z-0229-2016
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack by Resource Optimization And Innovation, citing the kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0229-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-25 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Resource Optimization And Innovation |
| Distribution | OK |
Product
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
The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
Identifiers
| code_info | Lot 25787E, exp. date 1/19/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.