Z-1348-2019Class II

MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S

Name: Z-1348-2019 MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Creator: Compass Health Brands (Corporate Office)
Published: 2019-04-08
License: https://open.fda.gov/license/

Compass Health Brands (Corporate Office) / initiated 2019-04-08 / Terminated / root cause: design

FDA source

Compass Health Brands (Corporate Office) began a recall of MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S on 2019-04-08. FDA classified it as Class II and gives the reason as "Product design change did not receive proper premarket clearance and lacks a 510 (k)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1348-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-08
Posted: 2019-05-15
Terminated: 2020-10-26
Recalling firm: Compass Health Brands (Corporate Office)
Product: MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: Product design change did not receive proper premarket clearance and lacks a 510 (k)
Root cause tag: design
FDA root cause: Device Design
Action: On April 8, 2019 Compass Health issued URGENT MEDICAL DEVICE RECALL notices and Response Forms to customers via courier service. Customers were advised to take the following actions: 1) Ensure all affected personnel are fully informed of this notice. Forward the notice to the Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. 2) Advise impacted customers regarding this recall. 3) Immediately check your stock for the model numbers and quarantine all affected product 4) Complete and return the Recall Response Form within fifteen (15) days of receipt of the notice via email to [email protected] or via fax to 440-268-2116. Customer with questions may call Compass Health Brands Corp. Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST 5:00 pm EST.
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
Product codes and lots: All Serial Numbers/Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1348-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1343-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1344-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1345-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1346-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1347-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1348-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15

Product code JOW

K974393Class IIVaso Press SystemBritt Corp., Inc. / cleared 1999-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)