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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 Device Recall 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod see related information
Date Initiated by Firm September 28, 2012
Date Posted October 11, 2012
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-0055-2013
Recall Event ID 63362
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 CA 92673-6212
For Additional Information Contact
949-366-2183
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		 Mixed-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 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 = DQO and Original Applicant = ABBOTT LABORATORIES
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