Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm
Summary
The FDA issued a Class II for Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 w by IHB OPERATIONS B.V.. Reason: Weakened connection point on the adjustable suspension arm, potentially causing damage or a break..
Details
Source
Device Recall
External ID
Z-0452-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
Lot/Code Info: UDI-DI: 10841736115951 (F110 SERIES), UDI-DI: 10841736115968 (F120 SERIES), UDI-DI: 10841736115975 (F130 SERIES), UDI-DI: 10841736116491 (F320 SERIES), UDI-DI: 10841736116545 (F330 SERIES), UDI-DI: 10841736116576 (F350 SERIES), UDI-DI: 10841736116590 (F410 SERIES), UDI-DI: 10841736116651 (F420 SERIES).
Quantity Affected: 1,497
Reason for Recall
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
Distribution
US: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MB, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-19
Company
Zwolle
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
IHB OPERATIONS B.V. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IHB OPERATIONS B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IHB OPERATIONS B.V. have FDA actions?
IHB OPERATIONS B.V. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0452-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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