Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
FDA Recall Z-0117-2022 · Posted 2021-10-14
Recalling FirmBeckman Coulter Inc.
Recall StatusOpen, Classified
Product CodeCDD
Date Initiated2021-07-28
Product QuantityTotal Units=271 units [258 units (3K and 3K HS); 13 units (5K added 12/15/2021)]
Reason for Recall
Missing splash guard which may expose users to hazardous materials. .
Firm Action
During the week of 08/30/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via its Field Action Notification process. On 09/16/2021, the Recalling Firm communicated a updated/revised "URGENT MEDICAL DEVICE RECALL" Notification letter which informed customer that, as a result of internal investigations, the Recalling Firm has discovered that the track-level splash guard has not been consistently provided to all customers. This guard is required for safe operation of the Power Processor system and could potentially cause user injuries if the splash guard is not in place.
Customer are being informed that a Recalling Firm Field Service representative will check their system for the splash guard. if the splash guard is not present, the Field Service representative will order and install it.
Customers are instructed to:
1. Continue to follow all safety warnings and system operation information provided in the Instructions for Use.
2. Share this information with their laboratory staff and to retain this notification as part of their laboratory Quality System documentation.
3. If customers have forwarded any of the affected products to another laboratory, provide a copy of this notification to them.
4. To confirm receipt of this Notification, customer are asked to respond within 10 days in one of the following ways:
-Electronically, if you received this communication via email.
-Manually, complete and return the enclosed Response Form.
Any questions, contact the Recalling Firm's Customer Support Center or their local representative via website http://www.beckmancoulter.com
Update 12/15/2021:
On 12/13/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter informing of additional products being added to the original Recall initiated in 08/2021 for the missing splash guards. A Recalling Firm's Representative will check the systems and if a splash guard is not present, they will order and install it. In addition, the Recalling Firm is a
Root Cause
Process control
Distribution Pattern
U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA, MI, MS, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WA, and WV O.U.S.: Canada, China, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Portugal, Qatar, Saudi Arabia, Thailand, Turkey, and Taiwan. Additional O.U.S. added 12/15/2021 - South Africa
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.