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U.S. Department of Health and Human Services

Class 2 Device Recall NIPRO, GLUCOPRO INSULIN SYRINGES

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  Class 2 Device Recall NIPRO, GLUCOPRO INSULIN SYRINGES see related information
Date Initiated by Firm January 13, 2010
Date Posted March 11, 2010
Recall Status1 Terminated 3 on September 15, 2010
Recall Number Z-1103-2010
Recall Event ID 54358
Product Classification Disposable Insulin Syringe - Product Code FMF
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".
Code Information A08022,  A08013,  A08017,  C08022,  C08013,  C08017,  B08013,  B08017.
Recalling Firm/
Manufacturer		 Nipro Medical Corporation
3150 Nw 107th Ave
Miami FL 33172
For Additional Information Contact Jessica Oswald
305-599-7174
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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