NIPRO…

Date posted by the FDA

March 11, 2010

Status

Terminated

Filed by

Nipro Medical Corporation

Product

NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). JD+01U3008-5C 1cc 30G x 5/16"; JD+01U3013-5C 1cc 30G x 1/2"; JD+01U3108-5C 1cc 31G x 5/16"; JD+03U3008-5C .3CC 30 g X 5/16"; JD+03U3013-5C .3CC 30 g X 1/2"; JD+03U3108-5C .3cc 31G x 516"; JD+05U3008-5C .5cc 30G x 5/16"; JD+05U3013-5C .5cc 30G x 1/2"; JD+05U3108-5C .5cc 31G x 5/16".

Reason

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

Distribution pattern

US (including Puerto Rico) Foreign Distribution: Canada, Barbados, Honduras, Jamaica, Panama, Trinidad and Tobago, and Costa Rica.

Quantity

2,268,600 pieces

Codes and lots

A08022, A08013, A08017, C08022, C08013, C08017, B08013, B08017.

Recall started

Jan. 13, 2010

Device type

Syringe, Piston

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

Each consignee will receive a Recall Notification Letter and response form by either fax or e-mail. Product should be returned to point of sale. Product not distributed should be collected and returned to Nipro Medical Warehouse in Memphis TN and Carolina Puerto Rico. Any questions or concerns can be addressed to the company at 787.769.2522.

Recall number

Z-1103-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1103-2010. The agency record governs; check it and the company before acting.