Z-0097-2019Class II

Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET...

Name: Z-0097-2019 Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET...
Creator: Bayer Medical Care, Inc.
Published: 2018-09-07
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2018-09-07 / Terminated / root cause: manufacturing process

FDA source

Bayer Medical Care, Inc. began a recall of Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter... on 2018-09-07. FDA classified it as Class II and gives the reason as "Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path". 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-0097-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-07
Posted: 2018-10-11
Terminated: 2019-07-11
Recalling firm: Medrad, Inc.
Product: Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
Product code: FPA Set, Administration, Intravascular
Reason for recall: Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Recall notification letters dated 9/7/18 were distributed to customers. The letters instruct customers to do the following: 1. Immediately discontinue use of your Intego system and quarantine the unused PAS product until further notice. 2. Contact Bayer Customer Care at 1-800-633-7231 opt. 2 or [email protected] to receive a Return Goods Authorization (RGA) number and return the Codan Filters to Bayer accordingly. 3. Complete the response form indicating if your institution does or does not have affected product. Return the form via fax (1-412-406-0942) or email ([email protected]).
Quantity in commerce: 1,142,836 (329,944 units in U.S.)
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, and WI. Foreign countries: UAE, Austria, Australia, Bosnia and Herzegovina, Belgium, Bahrain, Canada, China, Chile, Costa Rica, Czechia, Denmark, German, Spain, Estonia, Egypt, Finland, France, Great Britain, Croatia, Hungary, Israel, Italy, Jordan, Kuwait, Kazakhstan, Lebanon, Lithuania, Morocco, Malta, Mexico, Netherlands, Norway, Oman, Panama, Poland, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, and Turkey
Product codes and lots: Batch Numbers 14888 72498 72789 74023 75221 17061 72501 72790 74161 75277 20046 72529 72990 74162 75278 20056 72541 73365 74568 75434 70091 72639 73372 74569 75435 72354 72677 73600 74570 75482 72362 72713 73827 74571 75603 72365 72714 73944 74758 75625 72422 72788 74022 75220 75733

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0097-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0097-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-11

Product code FPA

K830755Class IIi.v. Sets Walrus Brand Various Configur-Medical Parameters, Inc. / cleared 1983-04-28

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)