Z-1319-2013 Class II Terminated
FDA device recall Z-1319-2013 was initiated by Summit Medical, Inc. on March 27, 2013 and is designated Class II. Reason for recall: 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). The recall status is terminated (terminated August 6, 2013). Affected quantity: 9 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- March 27, 2013
- Termination Date
- August 6, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 boxes
Product Description
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.
Reason for Recall
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).
Distribution Pattern
Distributed in MS, NY, PA and TX.
Code Information
Lot No. 121012