Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2109-2010

MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF...

Microtek Medical LLC / initiated 2010-05-25 / Terminated / root cause: labeling and UDI

Microtek Medical Inc began a recall of MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek... on . The reason FDA records is "Product labeled as sterile was distributed without sterilization". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2109-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Microtek Medical LLC
Product
MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microtekmed.com, CE0044, EC REP Microtek Medical B.V. , Zutphen, The Netherlands, Manufactured in the U.S.A. Suction probe for a smoke evacuation device
Product code
FYD Apparatus, Exhaust, Surgical
Reason for recall
Product labeled as sterile was distributed without sterilization.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
The firm notified its consignees of the problem and requested return of the product by telephone on 05/25/2010. They followed with a letter dated on 06/03/2010 re: Product Removal stating the reason for the recall and confirming the receipt of the recalled product. For further information please contact (662) 244-3220
Quantity in commerce
2 cases of 10 units
Distribution
Nationwide distribution including the states of Montana and Georgia
Product codes and lots
Lot Number C10133