Recall Z-0117-2022— Beckman Coulter Inc.

Name: FDA recall Z-0117-2022
Creator: U.S. Food and Drug Administration
Published: 2021-07-28

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-07-28. It names one FDA 510(k) clearance: K110413. Product: Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116. Reason: Missing splash guard which may expose users to hazardous materials. ..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-07-28
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110413 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONSBeckman Coulter, Inc.·cleared 2011-05-11

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

Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116

Reason for recall

Missing splash guard which may expose users to hazardous materials. .

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