CLASS II ONGOING Device recall · Reported 27 Mar 2019 · FDA Enforcement Report
Nelaton Urinary Catheter, disposable, sterile recalled by ConvaTec
ConvaTec is recalling Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit, distributed nationwide in the US. The recall was initiated on 9 Jan 2019 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-1037-2019
- FDA event ID
- 82039
- Recalling firm
- ConvaTec, Greensboro, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2019
- FDA classified
- 21 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 9 Jan 2019 | Recall initiated by company | |
| 21 Mar 2019 | Classified by FDA | +71 days |
| 27 Mar 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
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
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).
Where it was distributed
Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
Questions about this recall
Why was it recalled?
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Which lots are affected?
Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349
Where was it sold?
Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 82039| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit recalled | ConvaTec | Sterility | Nationwide | |
| CLASS II | FilterFlow Suction Handle CH24, 20 eaches per sales unit recalled | ConvaTec | Sterility | Nationwide | |
| CLASS II | Forceps Blue, disposable, sterile, 100 eaches per sales unit recalled | ConvaTec | Sterility | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Esteem Body Soft Convex Urostomy recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | Aquacel Ag Surgical SP recalled by ConvaTec | ConvaTec | Potency & Assay | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |