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U.S. Department of Health and Human Services

Class 2 Device Recall Bayer Medical Care

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  Class 2 Device Recall Bayer Medical Care see related information
Date Initiated by Firm November 30, 2022
Date Posted January 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-0910-2023
Recall Event ID 91273
510(K)Number K100798  
Product Classification Pump, infusion - Product Code FRN
Product Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile
Catalog number: INT CSS
Affected material number: 86566621

Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.
Code Information UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023
Recalling Firm/
Manufacturer		 Bayer Medical Care, Inc.
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information Contact SAME
412-406-3305
Manufacturer Reason
for Recall		 Black specks may be present on the packaged needles
FDA Determined
Cause 2		 Under Investigation by firm
Action Bayer US issued Urgent Medical Device Recall (RECALL ID: SA-22-RAD-05 ) Letter on 11/30/22 via email. Letter states reason for recall, health risk and action to take: 1. Review your current inventory for affected Lot 60272154 and quarantine, as appropriate. 2. Complete the included response form and submit through email to ricustomercare@bayer.com or contact our Bayer Customer Service team at 1-800-633-7231, Press 0, then option 3. Please complete the Customer Response Form regardless of whether you have affected product or not. This action will assist us in tracking all impacted product. 3. You will receive a Return Goods Authorization (RGA) number to return any affected kits remaining in your inventory for a credit. 4. Place the affected product in a box and label the outside of the container with the RGA number in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return affected product as soon as possible 5. Upon Bayer receipt of returned product, you will receive a credit on your account. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.
Quantity in Commerce 2840 units
Distribution Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDRAD, INC.
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