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U.S. Department of Health and Human Services

Class 2 Device Recall LIifeShield CLAVE

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  Class 2 Device Recall LIifeShield CLAVE see related information
Date Initiated by Firm September 09, 2013
Create Date June 29, 2016
Recall Status1 Terminated 3 on December 06, 2016
Recall Number Z-2060-2016
Recall Event ID 66372
510(K)Number K101677  
Product Classification Set, administration, intravascular - Product Code FPA
Product *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage:
The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
Code Information ***** CANADA DISTRIBUTION *****   *** 1) List Number 14220-28-01
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
Manufacturer Reason
for Recall		 Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
FDA Determined
Cause 2		 Device Design
Action Hospira sent an URGENT MEDICAL DEVICE CORECTION letters dated September 9, 2013 to customers. The letter identified the affected product, problem and actions to be taken. the letter included additional instructions on the proper handling/use of the CLAVE devices. The letters request that all incidents of separation or breakage of CLAVE from the secondary port of the cassette be reported to Hospira by calling 1-800-441-410 (Monday - Friday, 8:00 AM - 5:00 PM CST) or by e-mail at ProductComplaintPP@hospira.com. Customers are further requested to complete and return a response form included wih the URGENT MEDICAL DEVICE CORRECTION letter and to notify any customers of this advisory. Hospira will also be supplementing the instructions for CLAVE use as an interim measure until a new method for bonding the CLAVE to the secondary port of the Plum cassettes can be devised and implemented.
Quantity in Commerce 3,920,932 units in total
Distribution US (Nationwide) Distribution
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 = FPA and Original Applicant = HOSPIRA, INC.
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