Recall Z-1610-2013 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday INFUSOR 0.5ml/h System, Seven Day Infusor 0.5 ml/h, Seven Day INFUSOR 0.5ml/h System, Basal-Bolus Infusor-15min., Basal/Bolus
| Date | Jun 27, 2013 (initiated Jun 7, 2013) |
| Status | Terminated |
| Reason | Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. |
| Root cause | Device Design |
| Action | Baxter sent an Urgent Produd Recall notification letter dated June 13, 2013, to all affected consignees via USPS. The letter was accompanied by a Customer Reply Form and Affected Product List (table). The letter stated affected products, problem description, risk to health (or health risks), actions to be taken by customers/users and contact information. The recall notification instructs customers to segregate affected product from current inventory and contact Baxter for instructions to return affected product. Customers with questions were instructed to call Baxter at 1-800-437-5176, For qu |
| Quantity | 601,230 total |
| Distribution | Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884505 | BASAL/BOLUS INFUSORS Baxter Healthcare Corp, Jul 14, 1989 |