Recall Z-0007-2017— Baxter Corporation Englewood

Name: FDA recall Z-0007-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-24

Class I · Terminated

Class I FDA medical device recall by Baxter Corporation Englewood, initiated 2016-08-24, terminated 2017-07-26. It names one FDA 510(k) clearance: K900585. Product: 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.. Reason: Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present..

Recalling firm: Baxter Corporation Englewood
Classification: Class I
Status: Terminated
Initiated: 2016-08-24
Terminated: 2017-07-26
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K900585 — TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPBaxa Corp., Sub. of Cook Group, Inc.·cleared 1990-04-18

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

0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Reason for recall

Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.

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