Z-0985-2017Class II

MiniLoc Safety Infusion Set Winged without Y-Injection Site

Name: Z-0985-2017 MiniLoc Safety Infusion Set Winged without Y-Injection Site
Creator: Bard Access Systems
Published: 2016-12-19
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2016-12-19 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems began a recall of MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc... on 2016-12-19. FDA classified it as Class II and gives the reason as "Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0985-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Posted: 2017-01-10
Terminated: 2017-04-17
Recalling firm: Bard Access Systems, Inc.
Product: MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Bard sent an Urgent Notification letter dated December 16, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify and return affected product. For questions call 1-800-290-1689.
Quantity in commerce: 7,200 units
Distribution: Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX.
Product codes and lots: Lot Numbers: ASAQS0343 & ASZIS027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0985-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0985-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09
Z-0986-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code FPA

K050600Class IIMiniloc Safety Infusion SetSpecialized Health Products, Intl. / cleared 2005-05-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)