Home / Recalls / Bayer Medical Care, Inc. / Z-0097-2019

Z-0097-2019 Class II Terminated

Recalled by Bayer Medical Care, Inc. — Indianola, PA

FDA device recall Z-0097-2019 was initiated by Bayer Medical Care, Inc. on September 7, 2018 and is designated Class II. 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 recall status is terminated (terminated July 11, 2019). Affected quantity: 1,142,836 (329,944 units in U.S.).

Recall Details

Product Type
Devices
Report Date
October 17, 2018
Initiation Date
September 7, 2018
Termination Date
July 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,142,836 (329,944 units in U.S.)

Product Description

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

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.

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

Code Information

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

Other recalls by Bayer Medical Care, Inc.

  • Z-3147-2026 Class II — MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; (July 31, 2026)
  • Z-2296-2026 Class II — Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used (April 24, 2026)
  • Z-0910-2023 Class II — Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, (November 30, 2022)
  • Z-0199-2022 Class II — The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syring (September 14, 2021)
  • Z-0483-2021 Class II — Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syrin (October 5, 2020)
  • Z-0745-2019 Class II — MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjuncti (December 14, 2018)
  • Z-2961-2018 Class II — Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Ba (June 28, 2018)
  • Z-2960-2018 Class II — Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalo (June 28, 2018)
  • Z-2962-2018 Class II — Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalo (June 28, 2018)

FDA data resources