Recall Z-2375-2015 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
| Date | Aug 13, 2015 (initiated Jul 17, 2015) |
| Status | Terminated |
| Reason | Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators." |
| Root cause | Under Investigation by firm |
| Action | A Urgent recall letter will be sent to customers to inform them that Advanced Sterilization Products (ASP) is recalling the Wall Chart of the STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete a business reply card for their acknowledgement of the customer letter and documentation of the removal and replacement of the wall chart. Customers are |
| Quantity | 1465 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer Advanced Sterilization Products, Apr 3, 2015 |