U.S. Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: January 09, 2019
Create Date:March 21, 2019
Recall Status: Open, Classified
Recall Number: Z-1037-2019
Recall Event ID: 82039
510(K)Number: K896729
Product Classification: Catheter, urological - Product Code KOD
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).
Code Information: Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349
Recalling Firm/Manufacturer: ConvaTec, Inc
7900 Triad Center Dr Ste 400
Greensboro NC 27409-9076
For Additional Information Contact: 336-547-3730
Manufacturer Reason
for RecallAn internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
FDA Determined Cause: Package design/selection
ActionConvaTec 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.
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.
Total Product Life Cycle: TPLC Device Report
Original source can be found here.
