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Terminated

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.

FDA Recall Z-1319-2013 · Posted 2013-05-14

Recalling FirmSummit Medical, Inc.
Recall StatusTerminated
Product CodeJYO
Date Initiated2013-03-27
Date Terminated2013-08-06
Product Quantity9 boxes

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).

Firm 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.

Root Cause

Process control

Distribution Pattern

Distributed in MS, NY, PA and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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