Recall Z-0190-2014 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Nov 8, 2013 (initiated Oct 18, 2013) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps. |
| Root cause | Under Investigation by firm |
| Action | A recall letter was sent to all customers on 10/18/13 who purchased the Sterrad 100NX Sterilizer. The letter informed the customers of the problems identified and the actions to be taken. Customers are instructed to contact ASP Professional Services directly at (888) 783-7723 and select option #2. Customers are instructed to report any complaints or suspected problems with their Sterrad 100NX System to Stericycle at (877) 598-5705. |
| Quantity | 2106 units total (1224 units in US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA, SG, SI, TH, VE, VN, ZA, and Tripoli. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.