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
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