Z-0099-2015 Class II Terminated
FDA device recall Z-0099-2015 was initiated by Intra Pump Infusion Systems on October 18, 2013 and is designated Class II. Reason for recall: Product has the potential to have a clear debris on the tip of the needle. The recall status is terminated (terminated February 1, 2016). Affected quantity: 25,440 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2014
- Initiation Date
- October 18, 2013
- Termination Date
- February 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,440 pieces
Product Description
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Reason for Recall
Product has the potential to have a clear debris on the tip of the needle.
Distribution Pattern
Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
Code Information
Product Code CRN20, lot numbers 14N02, 15E01, 15A02