Recall Z-1038-2019 · JOL Catheter And Tip, Suction

ConvaTec, Inc

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.

Date	Jan 9, 2019
Status	Open, Classified
Reason	An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
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 ushcreturns@ups.com to report affected inventory on hand, forward
Quantity	124,000 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, K
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.