Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal
FDA device recall Z-2375-2015 · posted 2015-08-13 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- 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."
- Action taken
- 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 instructed to complete and return the attached Business Reply Card via mail or fax to Stericycle: 877-497-3125. Customers with questions are instructed to contact SteriCycle at 866-737-5389 and reference event #6677.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 1465 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-07-17
- Date posted
- 2015-08-13
- Date terminated
- 2016-05-20
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K142454) | Advanced Sterilization Products | 2015-04-03 |