Handicare USA, Inc.
Maryland Heights, MO, US
Handicare USA, Inc. appears in FDA device records in Maryland Heights, MO. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Handicare USA, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ergosafe Products LLC DBA Prism Medical Services USAenforcement report, recall
- ErgoSafe Products, LLC (DBA) Prism Medicalenforcement report, recall
- Handicare Accessibilityenforcement report, recall
- Prism Medical Services USAenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007802293 | 3007802293 | Handicare USA, Inc. | 10888 Metro Ct., Maryland Heights, MO 63043 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2753-2018 | Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another. | Premature strap wear and breakage at maximum weight conditions (625 lbs.). | Class II | Terminated | |
| Z-2752-2018 | Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another. | Premature strap wear and breakage at maximum weight conditions (625 lbs.). | Class II | Terminated | |
| Z-0013-2018 | PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered | During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop. | Class II | Terminated | |
| Z-1406-2017 | A-series lift - A625 Manual Part No. 324117. Prism Medical. | During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | Class II | Terminated | |
| Z-1405-2017 | A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical. | During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | Class II | Terminated | |
| Z-0728-2017 | Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757. | The black plastic puck on the carry bar is breaking resulting in potential for patient harm. | Class II | Terminated | |
| Z-0285-2016 | Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg. | Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use | Class II | Terminated | |
| Z-0284-2016 | Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members. | Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use | Class II | Terminated | |
| Z-2270-2015 | Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weight specification of 600 lbs (273 kg). Product Usage: The P-600 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member. | There is a potential the sling loops may not stay attached to the carry bar hooks. | Class II | Terminated | |
| Z-2269-2015 | Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). Product Usage: The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member. | There is a potential the sling loops may not stay attached to the carry bar hooks. | Class II | Terminated | |
| Z-1613-2015 | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid. | Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied. | Class II | Terminated | |
| Z-0303-2017 | ReTurn 7500/7500 Aid, transfer | During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder. | Class II | Terminated | |
| Z-0371-2014 | Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position. | The lift might fail with the labeled 500-lb. load rating. | Class II | Terminated | |
| Z-0370-2014 | Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position. | The lift might fail with the labeled 500-lb. load rating. | Class II | Terminated | |
| Z-1555-2013 | BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. | The product does not meet the firm's size standards, the product was produced in the incorrect size. | Class II | Terminated | |
| Z-1554-2013 | BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. | The product does not meet the firm's size standards, the product was produced in the incorrect size. | Class II | Terminated | |
| Z-1553-2013 | BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. | The product does not meet the firm's size standards, the product was produced in the incorrect size. | Class II | Terminated | |
| Z-1552-2013 | BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. | The product does not meet the firm's size standards, the product was produced in the incorrect size. | Class II | Terminated | |
| Z-1578-2013 | Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients. | The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars. | Class II | Terminated | |
| Z-0171-2014 | Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing. | Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain