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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 Recall
LifeShield HemoSet I.V. PlumSet
see related information
Date Posted April 21, 2014
Recall Status1 Open
Recall Number Z-1479-2014
Recall Event ID 67722
Premarket Notification
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, Illinois 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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 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 = FRN and Original Applicant = ABBOTT LABORATORIES
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