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U.S. Department of Health and Human Services

Class 2 Device Recall Summit Medical, BL2006, Myringotomy Lance (Juvenile) Blade

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 Class 2 Device Recall Summit Medical, BL2006, Myringotomy Lance (Juvenile) Bladesee related information
Date Initiated by FirmMarch 27, 2013
Date PostedMay 14, 2013
Recall Status1 Terminated 3 on August 06, 2013
Recall NumberZ-1319-2013
Recall Event ID 65034
Product Classification Ear Knives - Product Code JYO
ProductSummit 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.
Code Information Lot No. 121012
Recalling Firm/
Manufacturer		 Summit Medical, Inc.
815 Northwest Pkwy Ste 100
Eagan MN 55121-1658
For Additional Information Contact
651-789-3939
Manufacturer 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).
FDA Determined
Cause 2		Process control
ActionSummit 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 in Commerce9 boxes
DistributionDistributed in MS, NY, PA and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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