Recall record at a glance
| Official record | Z-0850-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Kimberly-Clark Corporation |
| Report date | Feb 5, 2014 |
| Recall initiation date | Oct 29, 2013 |
| Quantity | 55 cases (10 units per case = 550 units) |
| Location | Roswell, GA, United States |
Official product description
Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
Why the product was recalled
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
Distribution information
US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.
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: Letter.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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