FDA recall record

IHB OPERATIONS B.V Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and recall — FDA Z-0452-2024

Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

Class IIclassification
Z-0452-2024official record ID
Dec 13, 2023report date

Recall record at a glance

Official recordZ-0452-2024
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmIHB OPERATIONS B.V.
Report dateDec 13, 2023
Recall initiation dateJul 19, 2023
Quantity1,497
LocationZwolle, Netherlands

Official 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.

Why the product was recalled

Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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