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
FDA Recall Z-2109-2010 · Posted 2010-07-28
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Recalling FirmMicrotek Medical Inc
Recall StatusTerminated
Product CodeFYD
Date Initiated2010-05-25
Date Terminated2010-08-12
Product Quantity2 cases of 10 units
Reason for Recall
Product labeled as sterile was distributed without sterilization.
Firm 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
Root Cause
Other
Distribution Pattern
Nationwide distribution including the states of Montana and Georgia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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