Z-0627-2016Class II

Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump...

Name: Z-0627-2016 Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump...
Creator: Bayer Healthcare
Published: 2015-11-30
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2015-11-30 / Terminated / root cause: manufacturing process

FDA source

Bayer Healthcare began a recall of Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures on 2015-11-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0627-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-30
Posted: 2016-01-11
Terminated: 2016-11-18
Recalling firm: Medrad, Inc.
Product: Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Product code: FRN Pump, Infusion
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
Root cause tag: manufacturing process
FDA 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 [email protected], 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0627-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0627-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-11

Product code FRN

K100798Class IIMedrad Intego Pet Infusion System, Source Administration Set, Patient Adminstratin Set Model Int Sys 100, Int Css, Int CMedrad, Inc. / cleared 2010-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)