Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
This recall has been terminated (originally issued January 13, 2009).
- Company
- Sterilmed Inc
- Recall Initiated
- August 8, 2008
- Posted
- January 13, 2009
- Terminated
- April 26, 2011
- Recall Number
- Z-0563-2009
- Quantity
- 124
- Firm Location
- Osseo, MN
- Official Source
- View on FDA website ↗
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
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
Root Cause
Packaging process control
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.