Z-1703-2016Class II

WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports...

Name: Z-1703-2016 WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports...
Creator: B. Braun Medical, Inc.
Published: 2016-04-26
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2016-04-26 / Terminated / root cause: design

FDA source

B. Braun Medical, Inc. began a recall of WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage... on 2016-04-26. FDA classified it as Class II and gives the reason as "Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1703-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-26
Posted: 2016-05-20
Terminated: 2017-03-10
Recalling firm: B Braun Medical Inc
Product: WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, B. Braun Medical Inc., sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 4/26/2016 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate their current inventory for the affected lots; fill out the Product Removal Acknowledgement form and record the total number of units found, and return the form to B. Braun Medical Inc. Quality Assurance department by faxing the form to 610-849-1197 or email to PA_Quality [email protected] within two weeks of receipt. A BBMI Customer Support Representative will contact the customer to provide instructions for handling the affected product and arrange for return to BBMI. Should you have any questions or concerns regarding the attached information, please contact our Customer Support Department at (800) 227-2862.
Quantity in commerce: 5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]
Distribution: Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.
Product codes and lots: Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1703-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1703-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-20

Product code DQO

K760388Class IICatheter, Vein (Venofix)B. Braun Instruments / cleared 1976-11-02

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)