15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Reported: April 16, 2014 Initiated: March 20, 2014 #Z-1432-2014
Product Description
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Reason for Recall
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.
Details
- Recalling Firm
- Aspen Surgical Products, Inc.
- Units Affected
- N/A
- Distribution
- 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.
- Location
- Caledonia, MI
Frequently Asked Questions
What product was recalled? ▼
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage. Recalled by Aspen Surgical Products, Inc.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2014. Severity: Moderate. Recall number: Z-1432-2014.
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