Option-vf Urinary Catheter — Class II medical device recall Z-2830-2016
Terminated recall by C.R. Bard, Inc., reported 2016-09-21, distributed in AL, CA, CO, FL, IL, IN, MA, MD…. During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
| Recall number | Z-2830-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2016-07-11 |
| Classified | 2016-09-15 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-03-22 |
| Distributed | AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, WI |
| Quantity | 274 units |
| Reason classes | sterility |
| Lot numbers | P1007461, P1007637, P1007638 |
| Model numbers | FV14218 |
| Expiration dates | 2016-08-01 |
Product
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Reason for recall
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
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-2830-2016. 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.