Z-1103-2010

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

Name: Z-1103-2010 NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX...
Creator: Nipro Medical Corporation
Published: 2010-01-13
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2010-01-13 / Terminated / root cause: manufacturing process

FDA source

Nipro Medical Corporation began a recall of NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION... on 2010-01-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1103-2010
Status: Terminated
Initiated: 2010-01-13
Posted: 2010-03-11
Terminated: 2010-09-15
Recalling firm: 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".
Product code: FMF Syringe, Piston
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 2,268,600 pieces
Distribution: US (including Puerto Rico) Foreign Distribution: Canada, Barbados, Honduras, Jamaica, Panama, Trinidad and Tobago, and Costa Rica.
Product codes and lots: A08022, A08013, A08017, C08022, C08013, C08017, B08013, B08017.

Product code FMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)