Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended fo
FDA device recall Z-0559-2009 · posted 2009-01-13 · Terminated
Recall details
- Recalling firm
- Sterilmed Inc
- Reason for recall
- SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
- Action taken
- Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NLQ
- Quantity affected
- 14
- Distribution
- AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
- Date initiated
- 2008-08-08
- Date posted
- 2009-01-13
- Date terminated
- 2011-04-26
- Location
- Osseo, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPROCESSED HARMONIC SCALPELS (K050343) | Sterilmed, Inc. | 2005-04-12 |
| REPROCESSED HARMONIC (K012571) | Sterilmed, Inc. | 2001-11-07 |