FDA Medical Device Recalls (openFDA)
Bayer Healthcare: Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
- Recall number
- Z-0627-2016
- Recalling firm
- Bayer Healthcare
- Product
- Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
- Status
- Terminated
- Initiated
- 2015-11-30
- Posted
- 2016-01-11
- Terminated
- 2016-11-18
- Reason
- 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
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 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