Recall Z-2109-2010 ยท FYD Apparatus, Exhaust, Surgical
Microtek Medical Inc
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
| Date | Jul 28, 2010 (initiated May 25, 2010) |
| Status | Terminated |
| Reason | Product labeled as sterile was distributed without sterilization. |
| 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 | 2 cases of 10 units |
| Distribution | Nationwide distribution including the states of Montana and Georgia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001082 | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 Stackhouse, Inc., Jun 15, 2000 |