NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Dist

FDA device recall Z-1103-2010 · posted 2010-03-11 · Terminated

Recall details

Recalling firm

Nipro Medical Corporation

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

Action taken

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

Status

Terminated

Product code

FMF

Quantity affected

2,268,600 pieces

Distribution

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

Date initiated

2010-01-13

Date posted

2010-03-11

Date terminated

2010-09-15

Location

Miami, FL