Recall Z-1319-2013 ยท JYO Knife, Ear
Summit Medical, Inc.
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.
| Date | May 14, 2013 (initiated Mar 27, 2013) |
| Status | Terminated |
| 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). |
| Root cause | Process control |
| Action | Summit Medical sent a Medical Device Recall letter dated March 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately examine your inventory, and quarantine the product subject to this recall. Please complete and return the enclosed "Recall Response Form" as soon as possible. The fax number is (651) 789-3961. For further questions please call (651) 789-3921. |
| Quantity | 9 boxes |
| Distribution | Distributed in MS, NY, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.