Recall Z-1996-2014 ยท FPA Set, Administration, Intravascular
RGI Medical Manufacturing, Inc.
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
| Date | Jul 7, 2014 (initiated Mar 28, 2014) |
| Status | Terminated |
| Reason | Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use. |
| Root cause | Process control |
| Action | RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI |
| Quantity | 19,200 units. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001599 | ACTI-FLEX IV ADMINISTRATION SET R-Group Intl., Sep 18, 2000 |