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Recall Observatory FDA recall evidence

Device product

7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)

Z-1435-2014

March 20, 2014

Class II

Product summary

Firm
Aspen Surgical Products, Inc.
Event
Event 67757
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1435-2014

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 340004, 332259, 310003

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

    reason.no_named_rule · v1.0.0

    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.