Recall Z-0502-2011 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product code 2N3410 and A2N3410 - Japan Baxter Healthcare corporation, Deerfield, IL 60015 USA; Intended for use with a vascular access device for blood sampling and the administration of multiple drugs a
| Date | Dec 1, 2010 (initiated Oct 21, 2010) |
| Status | Terminated |
| Reason | If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. |
| Root cause | Other |
| Action | Baxter sent an "Urgent Device Correction" letter dated October 20, 2010, via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, informing them that there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. The loosening or disconnection can result in an interruption of therapy, potentially resulting in patient injury and death. The accounts were requested to place the notification where the inventory of affected product is dispensed, so that users are made aware of the procedu |
| Quantity | 752,965 units in US and all lots in Japan |
| Distribution | Worldwide Distribution -- United States and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970438 | INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS Baxter Healthcare Corp, Apr 2, 1997 |