Recall Z-1037-2019
ConvaTec, Inc · initiated January 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349
Reason for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
FDA-determined cause: Package design/selection
Action taken
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 ushcreturns@ups.com 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 ushcreturns@ups.com 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 ushcreturns@ups.com to report affected inventory on hand.
Details
- Recall number
- Z-1037-2019
- Initiated
- January 9, 2019
- Product code
- KOD – Catheter, Urological
- Quantity
- 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…
- Recalling firm
- ConvaTec, Inc, Greensboro, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1035-2019 Class II | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are…An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | 01/09/2019Open, Classified |
| Z-1036-2019 Class II | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray…An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | 01/09/2019Open, Classified |
| Z-1038-2019 Class II | FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is…An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | 01/09/2019Open, Classified |