FilterFlow Suction Handle CH24 recall: Sterility Concern
FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning…
Why was FilterFlow Suction Handle CH24 recalled?
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code/REF Number: 504159; Lot Codes: 176482, 189027
- Product
- FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning…
- Recalling firm
- ConvaTec, Inc
- 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, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)