Recall Z-0675-2016 ยท FPA Set, Administration, Intravascular
Rymed Technologies, LLC
InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
| Date | Jan 21, 2016 (initiated Jan 5, 2016) |
| Status | Terminated |
| Reason | Potential for the female luer component of the InVision-Plus IV connector to crack during use. |
| Root cause | Process design |
| Action | The firm Ry Med Technology LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 4, 2016 and response form to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use and return the product to: RyMed Technologies LLC, 6000 W. William Cannon Drive, Building B, Suite 300 Austin, TX 78749; the user facilities to change the IV connectors in 24 hour when lipids are being administered; if further distributed, contact other accounts, advise of recall and return outstanding stock; complete and return the RECALL NOTIF |
| Quantity | 496,400 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM Rymed Technologies, Inc., Jun 24, 1999 |