Z-1996-2014 Class II Terminated
FDA device recall Z-1996-2014 was initiated by RGI Medical Manufacturing, Inc. on March 28, 2014 and is designated Class II. Reason for recall: Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use. The recall status is terminated (terminated September 29, 2016). Affected quantity: 19,200 units..
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2014
- Initiation Date
- March 28, 2014
- Termination Date
- September 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,200 units.
Product Description
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Reason for Recall
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Distribution Pattern
US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
Code Information
Lot numbers 102131 and 110531.