The Recall Desk
ModerateFDA (Devices)·Z-1319-2013·Announced 2013-05-22

Summit Medical Recalls Myringotomy Lance Blades Due to Incorrect Packaging

Summit Medical is recalling Myringotomy Lance Blades because the boxes contain the wrong type of blade.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall involving a labeling/packaging error where the wrong product is in the box. No injuries or illnesses are reported, and the hazard is a potential for incorrect surgical instrument use rather than a direct contamination or structural failure.

Plain-English summary

Summit Medical, Inc. has initiated a recall of Myringotomy Lance (Juvenile) Blades. The recall was initiated because the product boxes contain the wrong blade; specifically, the boxes contain Myringotomy Spear Blades (Juvenile) instead of the labeled Lance Blades.

The affected product is the Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P. The recall involves 9 boxes from Lot No. 121012. These products were distributed in Mississippi, New York, Pennsylvania, and Texas.

Healthcare providers and consumers should check their inventory for this specific lot number and product type. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions.

The recalled product

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.
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot No. 121012

Distribution

Distributed in 4 states:

Same manufacturer · Summit Medical, Inc.

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