WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per

FDA device recall Z-1703-2016 · posted 2016-05-20 · Terminated

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

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

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

DQO

Quantity affected

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.

Date initiated

2016-04-26

Date posted

2016-05-20

Date terminated

2017-03-10

Location

Allentown, PA

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