Terminated

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

FDA Recall Z-0097-2019 · Posted None

Recalling FirmBayer Medical Care, Inc.

Recall StatusTerminated

Product CodeFPA

Date Initiated2018-09-07

Date Terminated2019-07-11

Product Quantity1,142,836 (329,944 units in U.S.)

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.

Firm 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]).

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K830755I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-Medical Parameters, Inc. · 1983-04-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.