CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report
SLC 3-way standard Lubricious Coated 20Ch/Fr/cc recalled by Convatec
Convatec is recalling SLC 3-way standard Lubricious Coated 20Ch/Fr/cc, distributed in Texas. The recall was initiated on 7 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1241-2014
- FDA event ID
- 67588
- Recalling firm
- Convatec, Skillman, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2014
- FDA classified
- 19 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Feb 2014 | Recall initiated by company | |
| 19 Mar 2014 | Classified by FDA | +40 days |
| 26 Mar 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 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.
Where it was distributed
Worldwide Distribution and in the state of TX
Questions about this recall
Is SLC 3-way standard Lubricious Coated 20Ch/Fr/cc recalled?
Yes. Convatec recalled SLC 3-way standard Lubricious Coated 20Ch/Fr/cc on 7 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1241-2014.
Why was it recalled?
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Which lots are affected?
540204R001
Where was it sold?
Worldwide Distribution and in the state of TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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