FDA Medical Device Recalls (openFDA)
Bayer Medical Care, Inc.: 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.
- Recall number
- Z-0910-2023
- Recalling firm
- Bayer Medical Care, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2022-11-30
- Posted
- 2023-01-06
- Terminated
- not on file
- Reason
- Black specks may be present on the packaged needles
- Root cause
- 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
- 2840 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
- Lot, serial or model codes
- UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023
- 510(k) numbers
- ["K100798"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28