Miami, Florida-based Nipro Medical has initiated a nationwide recall of all its GlucoPro Insulin Syringes, excluding the GlucoPro syringe specific for use with the Amigo Insulin pump. The recalled syringes may have needles that detach from the syringe.
If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.
The recall includes all product codes and lot numbers with expiration dates before Nov 1, 2011. The product code for the recalled lots are: JD+01U3008-5C, JD+01U3013-5C, JD+01U3013-5C, JD+01U3108-5C, JD+01U3108-5C, JD+03U3008-5C, JD+03U3013-5C, JD+03U3013-5C, JD+03U3108-5C, JD+03U3108-5C, JD+05U3008-5C, JD+05U3013-5C, JD+05U3013-5C, JD+05U3108-5C, JD+05U3108-5C.
The company claims that it voluntarily recalled the products after learning of the possibility of needle detachment, and FDA has been appraised of this action. Product were distributed nationwide, including Puerto Rico, and no injuries have been reported to date.
The company said that it is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program. It also said that consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.