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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Intego PET Infusion System, Source Administration Set

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  Class 2 Device Recall MEDRAD Intego PET Infusion System, Source Administration Set see related information
Date Initiated by Firm November 30, 2015
Date Posted January 11, 2016
Recall Status1 Terminated 3 on November 18, 2016
Recall Number Z-0627-2016
Recall Event ID 72817
510(K)Number K100798  
Product Classification Pump, infusion - Product Code FRN
Product Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Code Information 50856405, 50857510, 50860994, 50866789, 50867921, 50869464, 50869465, 50871131, 50872965, 50878229, 50878230, 50878231, 50878232, 50881328, 50881393, 50881394, 50881395, 50881506, 50881511, 50881512, 50882753, 50886316, 50886467, 50886468, 50886469, 50888285, 50888286, 50888287, 50888288, 50888373, 50890483, 50890484, 50890485, 50892357, 50892358, 50892359, 50892360, 60000321, 60000322, 60000323, 60000692, 60000789, 60000790, 60000833, 60000834, 60000835 
Recalling Firm/
Bayer Healthcare
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information Contact
Manufacturer Reason
for Recall
The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail
FDA Determined
Cause 2
Nonconforming Material/Component
Action Bayer Healthcare sent an "Urgent Medical Device Field Corrective Action" letter dated November 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately take the following steps. Please review your current inventory. Do not use any Source Administration Sets (SAS) with the impacted batch numbers that are included in the index below. If you have unused affected product, immediately quarantine the product and please call Bayer Customer Service at 1-800-633-7231 to receive a Returned Goods Authorization (RGA) number and return the product immediately to Bayer accordingly. Please complete the response form and fax it to Bayer at 1-412-406-0942 or e-mail to randiproductrecalls@bayer.com, whether or not you have impacted product. To provide you with new product, please submit a new product order. Please note that due to limited new inventory, there may be a delay in fulfillment. New batches of SAS are currently being shipped and lead times will be dependent on available supply until inventory returns to normal levels. We appreciate your cooperation and sincerely regret any inconvenience. We are committed to providing effective products and service to support your patient care. If you have questions, please contact our customer support team at 1-800-633-7231.
Quantity in Commerce 198,598
Distribution Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI.
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 = FRN and Original Applicant = MEDRAD, INC.