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U.S. Department of Health and Human Services

Class 2 Device Recall 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod

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 Class 2 Recall
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod
see related information
Date Posted October 11, 2012
Recall Status1 Terminated on February 19, 2013
Recall Number Z-0055-2013
Recall Event ID 63362
Premarket Notification
510(K) Number
K914299 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Code Information Part Number (Item #) AG8049-NS, Lot # 2528655.
Recalling Firm/
Manufacturer
ICU Medical, Inc.
951 Calle Amanecer
San Clemente, California 92673-6212
Manufacturer Reason
for Recall
ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com" for questions regarding this notice.
Quantity in Commerce 60
Distribution Nationwide distribution: Virginia only.
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 = DQO and Original Applicant = ABBOTT LABORATORIES
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