FDA Medical Device Recalls (openFDA)
Cincinnati Sub-Zero Products Inc: FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
- Recall number
- Z-0781-2010
- Recalling firm
- Cincinnati Sub-Zero Products Inc
- Product
- FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
- Status
- Terminated
- Initiated
- 2009-11-14
- Posted
- 2010-02-04
- Terminated
- 2012-01-25
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Product # 82542; Catalog # 542; Lot #: 07279, 07280, 07424 & 08813.
- 510(k) numbers
- ["K942599"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 1516825
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28