Class II — Aspen Surgical Products, Inc.
| Recalling firm | Aspen Surgical Products |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage |
| Quantity | 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. |
| Initiated | 2014-03-20 |
| Classified | 2014-04-07 |
| Terminated | 2014-11-25 |
| Recall number | Z-1433-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Aspen Surgical Products, Inc. (Z-1433-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67757/
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