FDA recall record

Primus Medical AC Powered adjustable bed frame recall — FDA Z-0067-2015

Firm received several complaints that the head deck actuator bracket had separated from the bed frame.

Class IIclassification
Z-0067-2015official record ID
Oct 22, 2014report date

Recall record at a glance

Official recordZ-0067-2015
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmPrimus Medical LLC
Report dateOct 22, 2014
Recall initiation dateSep 15, 2014
Quantity1726
LocationBoardman, OH, United States

Official product description

AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.

Why the product was recalled

Firm received several complaints that the head deck actuator bracket had separated from the bed frame.

Distribution information

Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, GA, IL, IN, KS, KY, MA, MN,MS, NC, NM, NV, NY, OH, PA, TN, TX, and VA, and the country of Canada.

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

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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