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U.S. Department of Health and Human Services

Class 2 Device Recall Live Better U100 Insulin Syringe

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 Class 2 Recall
Live Better U100 Insulin Syringe
see related information
Date Posted March 31, 2010
Recall Status1 Terminated on May 07, 2011
Recall Number Z-1217-2010
Recall Event ID 54655
Premarket Notification
510(K) Number
K062702 
Product Classification Syringe, Piston - Product Code FMF
Product Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare. Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock or saline lock.
Code Information Lot 171124
Recalling Firm/
Manufacturer
Ulti Med, Inc.
287 6th St E Ste 20
Saint Paul, Minnesota 55101-1655
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Holly Hartshorn
651-291-7909
Manufacturer Reason
for Recall
UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe.
FDA Determined
Cause 2
TRAINING: Employee Error
Action An " IMPORTANT - DEVICE PRODUCT RECALL"letter dated February 3, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. The customers should check their inventory for the affected lot, complete the recall tracking form and return by mail or fax and contact UltiMed for return instructions. If you have any questions concerning this recall, please call UltiMed, Inc. at 877-854-3434 and ask to speak to Jill.
Quantity in Commerce 25 units (each dispense and dispose sharps unit contains 100 syringes)
Distribution Nationwide distribution: CT and NJ
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = ULTIMED, INC.
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