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Medication 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 – 90o Huber Needle and Wing (22 gauge/1 inch) .This recall was issued because the tip of the Huber needle on the WHIN Infusion Set may stick out of the needle guard. This could cause a hole in the packaging and could affect the sterility of the product. The exposed needle could also cause an accidental needle stick.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

Using product that is not sterile could cause a serious infection that may be life threatening. Also, the potential for a needle stick injury prior to use also exists. A “clean” needle stick injury has a small chance of a health risk but may cause a mild infection if the needle is not sterile.

This recall affects lot numbers 0061482060 and 0061486821. To see if you have affected product, please check the lot number. The lot number is located on the bottom of the manufacturer’s label. If your product is not from these affected lots, it is not affected by this recall. If your product is from one of these affected lots, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall.

CVS Caremark Response: This product is carried by the CVS Specialty Pharmacies only. If you are currently using WHIN® Infusion sets – 90o Huber Needle and Wing (22 gauge/1 inch), please call your Specialty pharmacy toll-free at the number on your prescription label. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently using WHIN® Infusion sets – 90o Huber Needle and Wing (22 gauge/1 inch and have questions regarding this recall, please call your doctor or call B. Braun Medical toll-free at 1-800-854-6851 or visit https://www.bbraunusa.com/.

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

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