Recall Z-1038-2019
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
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.
Codes / lots: Product Code/REF Number: 504159; Lot Codes: 176482, 189027
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-1038-2019
- Initiated
- January 9, 2019
- Product code
- JOL – Catheter And Tip, Suction
- 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, 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-1037-2019 Class II | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as:…An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | 01/09/2019Open, Classified |