Regard Custom Surgical Pack — Class II medical device recall Z-0229-2016
Terminated recall by Resource Optimization & Innovation Llc, reported 2015-11-11, distributed in OK. The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction iss
| Recall number | Z-0229-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation Llc, Springfield, MO, United States |
| Recall initiated | 2015-08-25 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2017-04-06 |
| Distributed | OK |
| Quantity | 255 packages |
| Lot numbers | 25787E |
| Model numbers | 880239 |
| Expiration dates | 2017-01-19 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0229-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.