SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage:… — Class II medical device recall Z-1238-2014
Terminated recall by Convatec Inc., reported 2014-03-26, distributed in TX. The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
| Recall number | Z-1238-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Convatec Inc., Skillman, NJ, United States |
| Recall initiated | 2014-02-07 |
| Classified | 2014-03-19 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2014-12-18 |
| Distributed | TX |
| Quantity | 5,540 catheters |
| Reason classes | sterility |
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.
Reason for recall
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
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-1238-2014. 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.