Z-1016-2017 Class II Terminated
FDA device recall Z-1016-2017 was initiated by Hospira Inc. on Feb 19, 2013 and is designated Class II. 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… The recall status is terminated (terminated Apr 24, 2017). Affected quantity: 48,050 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 18, 2017
- Initiation Date
- Feb 19, 2013
- Termination Date
- Apr 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,050 units
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution
Code Information
Product List Number: 14699-28; Lot Number: 17-077-NS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1016-2017
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026