Recall Z-0097-2019 ยท FPA Set, Administration, Intravascular
Bayer Medical Care, Inc.
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
| Date | Sep 7, 2018 |
| Status | Terminated |
| Reason | 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 | 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 ricustomercare@bayer.com 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 emai |
| Quantity | 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, Bahrai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- Medical Parameters, Inc., Apr 28, 1983 |