Z-1037-2019Class II

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM

Name: Z-1037-2019 Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM
Creator: ConvaTec, Inc
Published: 2019-01-09
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2019-01-09 / Open, Classified / root cause: packaging

FDA source

ConvaTec, Inc began a recall of Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile... on 2019-01-09. FDA classified it as Class II and gives the reason as "An internal assessment of packaging confirmed the potential for a breach in the sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1037-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-09
Posted: 2019-03-21
Recalling firm: ConvaTec Limited
Product: 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 code: KOD Catheter, Urological
Reason for recall: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: ConvaTec notified customers on about 01/09/2019 via "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Instructions included how to identify affected product on the primary packaging and/or shipping carton as well as specific instructions for distributors, retailers, and end users (hospitals, EMT services, others). Distributors were instructed to inspect their inventory for affected products, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-582-6514 or [email protected] to report affected inventory on hand, forward the recall notice package to customers if product was further distributed, and provide a complete list of all consignees to allow ConvaTec to perform effectiveness checks. Retailers were instructed to immediately stop distributing and quarantine any affected inventory, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-582-6514 or [email protected] to report affected inventory on hand, and post page one of the recall notice in a conspicuous location in the store. End users (hospitals, EMT service, others) were instructed to inspect inventory to confirm if any affected product codes are in inventory, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-422-8811 or [email protected] to report affected inventory on hand.
Quantity in commerce: 5,744,525 units total
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.
Product codes and lots: Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1037-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1035-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-21
Z-1036-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-21
Z-1037-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-21
Z-1038-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-27	2019-03-21

Product code KOD

K896729Class IINelaton-, Female - or Tiemann CatheterUnoplast A/S / cleared 1990-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)