—#115600

Product

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.

FDA product code: FPK — Tubing, Fluid Delivery
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K941214
Affected lot / code info: Product List Number: 14699-28; Lot Number: 17-077-NS

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 return label or require additional assistance contact Stericycle at 1-888-965-5821 between the hours of Bam to 5pm EST, Monday through Friday. To ensure proper and timely credit, follow the instructions on the return label for returning the product. Please visit http://expertezlabel.com to request additional labels for returning affected product. If you have distributed the product further, notify your accounts that received the product identified above of this recall and ask them to contact Stericycle to receive a reply form and return labels for returning the product. Please contact Hospira Customer Care at 1-877-946-7747, between the hours of 6am to 6pm CST, Monday through Friday, or your Hospira representative regarding replacement product availability. For further questions please call (224) 212-2000.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-02-19
Posted by FDA: 2017-01-11
Terminated: 2017-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115600. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.