Device product
Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.
Z-1319-2013
Product summary
- Event
- Event 65034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 boxes
- Official record key
device-enforcement:Z-1319-2013
Official wording
Reason: Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile).
Code information: Lot No. 121012
Distribution pattern: Distributed in MS, NY, PA and TX.
Derived failure modes
-
Unknown
Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile).