Recall Z-1016-2017 ยท FPK Tubing, Fluid Delivery
Hospira Inc.
Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
| Date | Jan 11, 2017 (initiated Feb 19, 2013) |
| Status | Terminated |
| Reason | Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy. |
| Root cause | Process control |
| Action | Hospira sent an Urgent Device Recall letter dated February 19, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please check your inventory and immediately quarantine any affected product. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. Inform healthcare professionals in your organization of this recall. Return affected product to Stericycle using the label provided with this letter. If you have not received a retu |
| Quantity | 48,050 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941214 | LIFESHIELD EXTENSION SET Abbott Mfg., Inc., Oct 3, 1994 |