Device recall: Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the…
Class II FDA enforcement event 74488. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The black plastic puck on the carry bar is breaking resulting in potential for patient harm.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
ErgoSafe Products, LLC (DBA) Prism Medical started this device recall on 30 Aug 2016. The firm address in the FDA record is in Maryland Heights, MO. FDA put the recall in Class II. FDA event 74488 has 1 product record. The first FDA enforcement report date is 21 Dec 2016. The record gives the status Terminated, with the termination date 18 Jul 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea
Recalling firm
ErgoSafe Products, LLC (DBA) Prism Medical, Maryland Heights, MO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | not greater than 17,964 units | Class II | Terminated | 21 Dec 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 2
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Jan 2017 | A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical. | Device | Class II | 2 |
| 8 Sep 2015 | Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs | Device | Class II | 2 |
| 24 Jun 2015 | Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification o | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-0728-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 74488. https://recallregister.com/fda/ii/74488/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea
- What quantity of product is in FDA event 74488?
- The FDA record gives this quantity:
not greater than 17,964 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.