Device product
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Z-1422-2014
Product summary
- Event
- Event 67757
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1422-2014
Official wording
Reason: The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Code information: Product Number 310101
Distribution pattern: Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
Derived failure modes
-
Unknown
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.