MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
FDA Recall Z-1348-2019 · Posted None
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Recalling FirmCompass Health Brands (Corporate Office)
Recall StatusTerminated
Product CodeJOW
Date Initiated2019-04-08
Date Terminated2020-10-26
Reason for Recall
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Firm 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.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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