Atlas FDA

MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA

FDA device recall Z-2109-2010 · posted 2010-07-28 · Terminated

Recall details

Recalling firm
Microtek Medical Inc
Reason for recall
Product labeled as sterile was distributed without sterilization.
Action taken
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
Root cause
Other
Status
Terminated
Product code
FYD
Quantity affected
2 cases of 10 units
Distribution
Nationwide distribution including the states of Montana and Georgia
Date initiated
2010-05-25
Date posted
2010-07-28
Date terminated
2010-08-12
Location
Columbus, MS

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Related 510(k) clearances

RecordFirmDate
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 (K001082)Stackhouse, Inc.2000-06-15