Class II — Convatec Inc.
| Recalling firm | Convatec |
|---|---|
| Registered facility | CONVATEC TRIAD LIFE SCIENCES, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. |
| Product | SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. |
| Quantity | 5,540 catheters |
| Distribution | Worldwide Distribution and in the state of TX |
| Initiated | 2014-02-07 |
| Classified | 2014-03-19 |
| Terminated | 2014-12-18 |
| Recall number | Z-1238-2014 |
| 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 — Convatec Inc. (Z-1238-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67588/
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