Recall Z-1319-2013— Summit Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Summit Medical, Inc., initiated 2013-03-27, terminated 2013-08-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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)..
- Recalling firm
- Summit Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-27
- Terminated
- 2013-08-06
- Firm location
- Eagan, MN, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.