Recall Z-0546-2009 ยท NKU Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Sterilmed Inc
Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon.
| Date | Jan 13, 2009 (initiated Aug 8, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Packaging process control |
| Action | 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- |
| Quantity | 85 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053188 | REPROCESSED BALOON INFLATION DEVICE Sterilmed, Inc., May 4, 2006 |