Z-0781-2010

FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient...

Name: Z-0781-2010 FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2009-11-14
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2009-11-14 / Terminated / root cause: labeling and UDI

FDA source

Cincinnati Sub-Zero Products Inc began a recall of FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming) on 2009-11-14. The reason FDA records is "Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0781-2010
Status: Terminated
Initiated: 2009-11-14
Posted: 2010-02-04
Terminated: 2012-01-25
Recalling firm: Gentherm Medical, LLC
Product: FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
Product code: DWJ System, Thermal Regulating
Reason for recall: Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.
Quantity in commerce: 1,095 Blankets
Distribution: Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
Product codes and lots: Product # 82542; Catalog # 542; Lot #: 07279, 07280, 07424 & 08813.

Product code DWJ

K942599Class IIWarm Air Warming UnitCincinnati Sub-Zero Products, Inc. / cleared 1995-01-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)