FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: 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.
- Recall number
- Z-1703-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-04-26
- Posted
- 2016-05-20
- Terminated
- 2017-03-10
- Reason
- Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
- 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 Assurance.BBMUS_Service@bbraun.com 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
- 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.
- Lot, serial or model codes
- Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.
- 510(k) numbers
- ["K760388"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28