Terminated

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".

FDA Recall Z-1103-2010 · Posted 2010-03-11

Recalling FirmNipro Medical Corporation

Recall StatusTerminated

Product CodeFMF

Date Initiated2010-01-13

Date Terminated2010-09-15

Product Quantity2,268,600 pieces

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.