Class II — C.R. Bard, Inc.
| Recalling firm | C. R. Bard, Inc. |
|---|---|
| Registered facility | View this company's 19 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating). |
| Product | Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irra… |
| Quantity | 10,290 units |
| Distribution | US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT. |
| Initiated | 2016-10-05 |
| Classified | 2016-11-16 |
| Terminated | 2021-10-08 |
| Recall number | Z-0600-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C.R. Bard, Inc. (Z-0600-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75365/
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