Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Sui

FDA device recall Z-1319-2013 · posted 2013-05-14 · Terminated

Recall details

Recalling firm

Summit Medical, Inc.

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).

Action taken

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

Status

Terminated

Product code

JYO

Quantity affected

9 boxes

Distribution

Distributed in MS, NY, PA and TX.

Date initiated

2013-03-27

Date posted

2013-05-14

Date terminated

2013-08-06

Location

Eagan, MN