Data Foundry

Medical device recalls 2016

WHIN Infusion Set — Class II medical device recall Z-1703-2016

Terminated recall by B. Braun Medical, Inc., reported 2016-06-01, distributed in AL, AR, CA, FL, GA, IL, IN, KY…. Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

Recall numberZ-1703-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmB. Braun Medical, Inc., Allentown, PA, United States
Recall initiated2016-04-26
Classified2016-05-20
Reported by FDA2016-06-01
Terminated2017-03-10
DistributedAL, AR, CA, FL, GA, IL, IN, KY, MA, MS, NJ, NV, OH, PA, SC, TN, TX, VA
Countries outside the USCA
Lot numbers0061482060, 0061486821
Model numbers471734
Expiration dates2021-01-31

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.

Reason for recall

Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1703-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.