Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These 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.
Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.
This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011).
| Product Code | Lot # | Expiry date |
|---|---|---|
| JD+01U3008-5C | A08022 | 2011-11 |
| JD+01U3013-5C | A08013 | 2011-06 |
| JD+01U3013-5C | A08017 | 2011-08 |
| JD+01U3108-5C | A08013 | 2011-06 |
| JD+01U3108-5C | A08017 | 2011-08 |
| JD+03U3008-5C | C08022 | 2011-11 |
| JD+03U3013-5C | C08013 | 2011-06 |
| JD+03U3013-5C | C08017 | 2011-08 |
| JD+03U3108-5C | C08013 | 2011-06 |
| JD+03U3108-5C | C08017 | 2011-08 |
| JD+05U3008-5C | B08022 | 2011-11 |
| JD+05U3013-5C | B08013 | 2011-06 |
| JD+05U3013-5C | B08017 | 2011-08 |
| JD+05U3108-5C | B08013 | 2011-06 |
| JD+05U3108-5C | B08017 | 2011-08 |
The firm voluntarily recalled the products after learning of the possibility of needle detachment. FDA has been apprised of this action.
No injuries have been reported to date.
Product was distributed nationwide, including Puerto Rico.
Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.
Consumers with questions may contact the company at 305.599.7174 x249.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178
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