Drug Safety Alerts

WHIN® Infusion sets – 90o Huber Needle and Wing (22 gauge/1 inch) Voluntary Recall

04/26/2016


On April 26, 2016, B. Braun Medical, Inc. issued a voluntary recall of WHIN^® Infusion sets – 90^o Huber Needle and Wing (22 gauge/1 inch). This recall was issued due to the potential of the tip of the Huber needle on the WHIN infusion set to be protruding from the needle guard. The needle tip has the potential to pierce through the product packaging, causing a hole that can compromise the sterility of the product. The exposed needle may also increase the chance of a needle stick injury to the clinician/user prior to product use.

Exposure of the needle tip may cause perforation of the blister packaging, the sterile barrier of the product, which has the potential to allow microbial contamination of the product. Intravenous administration of medication using a non-sterile product can result in serious infection that may be life-threatening. In addition, the potential for a needle stick injury prior to use of the product on a patient also exists. A “clean” needle stick injury has minimal health risk, but may cause a mild local infection if the needle is contaminated.

CVS Caremark Response: This product is carried by the CVS Specialty Pharmacies only. Because of this action, CVS Specialty Pharmacy is sending letters to members who received this product and their physicians.

For more information about this recall, health care providers may contact B. Braun Medical at 1‑800-854-6851 or visit www.bbraunusa.com.

You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov/Safety.