Recall record at a glance
| Official record | Z-2848-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Smith & Nephew, Inc. |
| Report date | Sep 28, 2016 |
| Recall initiation date | Jul 21, 2016 |
| Quantity | 45,455 devices (in the USA) |
| Location | Saint Petersburg, FL, United States |
Official product description
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.
Why the product was recalled
Sterility seal integrity failures on the Renasys Sterile Transparent Film
Distribution information
Nationwide Distribution to AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI, Hawaii, and Puerto Rico Argentina, Australia, Bermuda, Brazil, Brunai, Canada, Curacao, Germany, Great Britain, Hong Kong, Ireland, Jordan, Malaysia, New Zeland, Peru, Saudi Arabia, Serbia, Singapore, South Africa, SriLanka, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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