Recall Z-0694-2012 ยท FMI Needle, Hypodermic, Single Lumen
Merz Aesthetics, Inc.
MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.
| Date | Dec 16, 2011 |
| Status | Terminated |
| Reason | Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety. |
| Root cause | Packaging process control |
| Action | Merz Aesthetics Inc, initially contacted customers by telephone on December 16, 2011. They were informed that the wrong size cannula were sent with their last order and would need to be returned and a replacement order would be sent. . Merz Aesthetics sent a "Urgent Medical Device Recall" letter dated January 6, 2012. The letter identified the product the problem and the action needed to be taken by the customer. In addition, if you have further distributed this product, please identify your customers and notify them of this product recall. Your notification to your customers may be en |
| Quantity | 5 boxes (20 units per box) |
| Distribution | Nationwide Distribution including the states of CA, NY, OK, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970370 | TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE Tsk Laboratory, Japan, Apr 10, 1997 |