FDA Device recall Z-1238-2014
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter e…
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter e… by Convatec, citing the lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1238-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-07 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Convatec |
| Distribution | TX |
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
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Identifiers
| code_info | 540204R001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1238-2014%22
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