ConvaTec Nelaton Urinary Catheters: Sterile Packaging Risk
ConvaTec recalls Nelaton urinary catheters with potential sterile packaging breach. These disposable catheters may risk infection if not properly sealed. Consumers should check labels for CH16/40CM or CH14/40CM models.
Lower-risk recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Contact the company
What happened, in plain English
ConvaTec is recalling Nelaton urinary catheters that may have packaging breaches risking infection. This affects specific models sold with labels CH16/40CM or CH14/40CM. The recall is due to potential contamination from compromised sterile packaging. Read more at govinfonow.com/recall/69142-convatec-nelaton-urinary-catheters-sterile-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69142-convatec-nelaton-urinary-catheters-sterile-packaging-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1037-2019
Cite this page
“ConvaTec Nelaton Urinary Catheters: Sterile Packaging Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69142-convatec-nelaton-urinary-catheters-sterile-packaging-risk. Based on FDA recall #Z-1037-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1037-2019%22&limit=1).
Why it’s dangerous
The sterile packaging could be breached, allowing contamination. This might lead to urinary tract infections if the catheter is not properly sealed. The risk is low as the catheters are designed for single use.
Who’s affected
People using urinary catheters for temporary bladder drainage may be affected. Those with medical conditions requiring catheter use are most at risk.
How to tell if you have this one
Check for labels marked CH16/40CM or CH14/40CM on the catheter packaging. These models were sold with specific lot codes 222348 or 222349.
- Brand
ConvaTec- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1035-2019 | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.; Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969 | 24,822,068 devices total |
| Z-1036-2019 | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.; Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048 | 1,231,155 units total |
| Z-1037-2019 | 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).; Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349 | 5,744,525 units total |
| Z-1038-2019 | FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.; Product Code/REF Number: 504159; Lot Codes: 176482, 189027 | 124,000 units total |
What to do — step by step
Check Product Label
Look for labels indicating CH16/40CM or CH14/40CM on the catheter packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Michigan, Pennsylvania, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Can I still use these catheters?
The recall does not require immediate stop-use; however, check for packaging issues before use.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1037-2019 (January 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1037-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.