Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
Recall
- Recall Number
- Z-0565-2009
- Event Number
- 49510
- Firm
- Sterilmed Inc
- FEI Number
- 3001237663
- Product Code
- NKX
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- August 8, 2008
- Posted
- January 13, 2009
- Terminated
- April 26, 2011
- Address
- 11400 73rd Ave N, Ste 100, Osseo, MN, 55369-5562
Description
Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
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
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.
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
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