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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield HemoSet I.V. PlumSet

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  Class 2 Device Recall LifeShield HemoSet I.V. PlumSet see related information
Date Initiated by Firm February 25, 2014
Date Posted April 21, 2014
Recall Status1 Terminated 3 on November 28, 2016
Recall Number Z-1479-2014
Recall Event ID 67722
510(K)Number K982159  
Product Classification Pump, infusion - Product Code FRN
Product LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette.

For administration of blood and blood bags for use with Plum Series Infusers.
Code Information Product List Number: 112410403; Lot Numbers: 280055H, 341005H
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Hospira Global Complaint Management
800-441-4100
Manufacturer Reason
for Recall		 Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Hospira sent a URGENT MEDICAL DEVICE RECALL letter dated February 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) check their inventory and immediately quarantine any affected product; 2) complete the attached reply form and return it to the fax number or e-mail address on the form; 3) inform potential users within the direct account's organization of this product of the recall; 4) return affected products to Stericycle using labels provided with the notification; and 5) follow the instructions on the return label for returning products. Additional labels and guidance on returning products can be obtained by calling Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET). If the recalled products were further distributed, the recall notification documents should be forwarded to those accounts. Those accounts can contact Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain a reply form and guidance on the return process.
Quantity in Commerce 3,893 sets
Distribution US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ABBOTT LABORATORIES
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