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U.S. Department of Health and Human Services

Class 2 Device Recall Intravascular Administration Set and Extension Set

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 Class 2 Recall
Intravascular Administration Set and Extension Set
see related information
Date Posted June 29, 2011
Recall Status1 Terminated on November 28, 2011
Recall Number Z-2707-2011
Recall Event ID 58576
Premarket Notification
510(K) Number
K051499 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
Code Information Lot Numbers: 10128001, 11018001, 11018002, 11018003, 11018007, 11018012, 11018013,
Recalling Firm/
Manufacturer
Carefusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego, California 92121-4386
For Additional Information Contact Krishna Uppugonduri
858-617-5925
Manufacturer Reason
for Recall
Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component.
FDA Determined
Cause 2
DESIGN: Device Design
Action CareFusion initiated on May 3, 2011, two distinctive "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via mail delivery, to all affected customers and distributors. The notices identified the product, the problem, and the actions to be taken. Customers were instructed to 1.) Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card to CareFusion. Note on the card your distributor, the MaxPlus bifuse extension set lot numbers and quantities that will be returned. 2.) All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods number through their distributor or CareFusion. 3.) Also, enclosed is a Frequently Asked Question (FAQ) Letter to address any questions or concerns related to the use of the MaxPlus" bifuse extension sets. The second notification was specifically addressed to distributors. The distributors were provided specific instructions for product returned. For customers who may have questions, please contact your distributor directly, or call the CareFusion Support Center at 1-800- 562-6018. The Support Center will be in operation from 7 a.m. - 4 p.m. PST. For distributors who may have any questions or require additional materials, please contact the CareFusion Support Center at 1800- 562-6018. Additionally, instructions were given to report adverse reactions experienced via the FDA's Med Watch Program.
Quantity in Commerce 26,150 units
Distribution Nationwide Distribution -- USA including states of: CA, IA, IN, and TX
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 = FPA and Original Applicant = MEDEGEN MEDICAL MANUFACTURING SERVICES
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