Recall Z-0781-2010
Cincinnati Sub-Zero Products Inc · initiated November 14, 2009
Product
FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
Codes / lots: Product # 82542; Catalog # 542; Lot #: 07279, 07280, 07424 & 08813.
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0781-2010
- Initiated
- November 14, 2009
- Posted by FDA
- February 4, 2010
- Terminated
- January 25, 2012
- Product code
- DWJ – System, Thermal Regulating
- 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.
- Recalling firm
- Cincinnati Sub-Zero Products Inc, Cincinnati, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0782-2010 | TempPad Cold Therapy Pad. The device is used for localized temperature therapy including…Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging… | 11/14/2009Terminated |