Aspen Surgical Recalls Sterile Drain Kits Due to Sterility Compromise
Aspen Surgical Products is recalling specific sterile drain kits and bulb evacuators because the sterile barrier may be compromised.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential compromise of the sterile barrier for medical devices, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Aspen Surgical Products, Inc. is recalling specific sterile medical devices, including the 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, the 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb, and the 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System. The recall involves product numbers 340004, 332259, and 310003.
The recall was initiated due to a potential compromise of the sterile barrier for the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. The source text does not report any specific illnesses, injuries, or deaths associated with these devices.
The affected products were distributed worldwide, including in the United States (specifically listing states such as LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, AZ, NJ, MO, GA, KS, WV, NE, and Puerto Rico) and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador. Consumers and healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- 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)
- Manufacturer
- Aspen Surgical Products, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number 340004
- 332259
- 310003
Distribution
Part of a larger recall action
This product is one of 19 recalled by Aspen Surgical Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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