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Recall Observatory FDA recall evidence

Device 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.

Z-1319-2013

March 27, 2013

Class II

Product summary

Firm
Summit Medical, Inc.
Event
Event 65034
Status
Terminated
Classification
Class II
Quantity
9 boxes
Official record key
device-enforcement:Z-1319-2013

Official wording

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).

Code information: Lot No. 121012

Distribution pattern: Distributed in MS, NY, PA and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).