Recall Z-0097-2019— Bayer Medical Care, Inc.

Name: FDA recall Z-0097-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-07

Class II · Terminated

Class II FDA medical device recall by Bayer Medical Care, Inc., initiated 2018-09-07, terminated 2019-07-11. It names one FDA 510(k) clearance: K830755. 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. 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..

Recalling firm: Bayer Medical Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-07
Terminated: 2019-07-11
Firm location: Indianola, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K830755 — I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-Medical Parameters, Inc.·cleared 1983-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.