Convatec Latex Foley Catheters Recalled Due to Blocked Lumen
Convatec Inc. is recalling 4,760 SLC 3-way standard latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect (blocked lumen) in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Convatec Inc. is recalling 4,760 units of SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Foley catheters. The recall was initiated after it was discovered that the lumen of the catheters was blocked by excess lubricious coating material.
The affected products are latex lubricous coated Foley catheters that incorporate one major drainage lumen and one or two minor lumens. The minor lumens are used for inflating the retention balloon and, in the case of 3-way catheters, for bladder irrigation. The blockage in the major drainage lumen compromises the device's intended function.
The recall number is Z-1241-2014, and the product code is 540204R001. The products were distributed worldwide and in the state of Texas. Consumers and healthcare providers should stop using the affected catheters and contact Convatec Inc. for further instructions or a replacement.
The recalled product
- Product
- SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product 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
- Manufacturer
- Convatec Inc.
- Category
- Medical Device — Foley Catheters
- Affected units
- 4,760
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 540204R001
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 recalled by Convatec Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Convatec Inc.
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- ModerateAquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
FDA (Devices) · 2026-07-15
- HighConvaTec EsteemBody drainable pouch REF 423653 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423657 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423643 may leak
FDA (Devices) · 2026-03-25
Same hazard · blocked lumen
See all →- HighEndoVive 20Fr Push Safety PEG Kit Recall Due to Blocked Lumen Risk
FDA (Devices) · 2024-04-17
- HighPEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement
FDA (Devices) · 2024-04-17
- HighFeeding tube kit recalled due to blocked connector preventing guidewire advancement
FDA (Devices) · 2024-04-17
- HighConvatec Recalls Latex Foley Catheters Due to Blocked Lumen
FDA (Devices) · 2014-03-26
- HighConvatec SLC Foley Catheters Recalled for Blocked Lumens
FDA (Devices) · 2014-03-26