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.
FDA Recall Z-1217-2010 · Posted 2010-03-31
Advertisement
Recalling FirmUlti Med, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2010-02-05
Date Terminated2011-05-07
Product Quantity25 units (each dispense and dispose sharps unit contains 100 syringes)
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide distribution: CT and NJ
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement