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-1038-2019
Recall Event ID: 82039
Product Classification: Catheter and tip, suction - Product Code JOL
Product: 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.
Code Information: Product Code/REF Number: 504159; Lot Codes: 176482, 189027
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
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 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: 124,000 units total
DistributionWorldwide 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.
