Z-1016-2017Class II

Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free

Name: Z-1016-2017 Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free
Creator: Hospira Inc.
Published: 2013-02-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-02-19 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of 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... on 2013-02-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1016-2017
Classification: Class II
Status: Terminated
Initiated: 2013-02-19
Posted: 2017-01-11
Terminated: 2017-04-24
Recalling firm: Abbott Medical
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.
Product code: FPK Tubing, Fluid Delivery
Reason for recall: 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 tag: manufacturing process
FDA 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 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.
Quantity in commerce: 48,050 units
Distribution: Nationwide Distribution
Product codes and lots: Product List Number: 14699-28; Lot Number: 17-077-NS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1016-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1016-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code FPK

K941214Class IILifeshield Extension SetAbbott Mfg., Inc. / cleared 1994-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)