Device recall: MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Class II FDA enforcement event 82629. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product design change did not receive proper premarket clearance and lacks a 510 (k)
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
Compass Health Brands (Corporate Office) started this device recall on 8 Apr 2019. The firm address in the FDA record is in Middleburg Heights, OH. FDA put the recall in Class II. FDA event 82629 has 6 product records. The first FDA enforcement report date is 22 May 2019. The record gives the status Terminated, with the termination date 26 Oct 2020.
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.
Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada
Recalling firm
Compass Health Brands (Corporate Office), Middleburg Heights, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1343-2019 | MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S | Class II | Terminated | 22 May 2019 | |
| Z-1344-2019 | MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S | Class II | Terminated | 22 May 2019 | |
| Z-1345-2019 | MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S | Class II | Terminated | 22 May 2019 | |
| Z-1346-2019 | MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S | Class II | Terminated | 22 May 2019 | |
| Z-1347-2019 | MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S | Class II | Terminated | 22 May 2019 | |
| Z-1348-2019 | MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S | Class II | Terminated | 22 May 2019 |
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 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Mar 2023 | REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ach | Device | Class II | 1 |
| 10 Jan 2022 | Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager | Device | Class II | 1 |
| 18 Jun 2018 | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an e | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-1343-2019The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82629. https://recallregister.com/fda/ii/82629/. 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:
Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.
- How many FDA recalls does Compass Health Brands (Corporate Office) have?
- Compass Health Brands (Corporate Office) is the recalling firm in 4 enforcement events on this register. This event is 1 of them.