Z-0731-2016 Class II Terminated
FDA device recall Z-0731-2016 was initiated by Baxter Corporation Englewood on December 21, 2015 and is designated Class II. Reason for recall: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product. The recall status is terminated (terminated August 18, 2016). Affected quantity: 4,695.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2016
- Initiation Date
- December 21, 2015
- Termination Date
- August 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,695
Product Description
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Reason for Recall
All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
Code Information
All Lots