Revanesse Lips+ with Lidocaine 1.2 mL
Prollenium Medical · Model 40149 · UDI-DI 10669808003032
Description
Revanesse® Lips+ is manufactured by Prollenium Medical Technologies, and is a biocompatible, biodegradable, non-pyrogenic, sterile, injectable viscoelastic clear colorless hydrogel based on bioresorbable BDDE cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration) containing 0.3% lidocaine. The HA is produced by the Streptococcus species of bacteria. The gel is delivered in a pre-filled disposable glass syringe. Each syringe is fitted with a Luer lock adaptor, a plunger rod, a rubber stopper tip cap, and a finger grip. Each box of Revanesse® Lips+ contains two 1.2 mL syringes of Revanesse® Lips+ along with two 0.5-inch 30-gauge sterile needles. The syringe is labeled with the product name, the manufacturer, lot number, and expiration date. There is a removable portion of the label, which can be affixed to the patient record.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-15 | Prollenium Medical Technologies Inc. | Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. |
| 2016-05-20 | Merz North America, Inc. | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. |
| 2015-10-26 | Merz North America, Inc. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
| 2015-02-26 | Orthovita, Inc., dBA Stryker Orthobiologics. | Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time. |
| 2013-08-07 | Enhancement Medical, LLC | Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of p |
| 2011-08-18 | Merz Aesthetics, Inc. | There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be a |
| 2011-04-06 | Merz Aesthetics, Inc. | Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specificat |
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