7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb — Class II medical device recall Z-1423-2014
Terminated recall by Aspen Surgical Products, Inc., reported 2014-04-16, distributed in AR, AZ, CA, CO, CT, DE, FL, GA…. The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drai
| Recall number | Z-1423-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aspen Surgical Products, Inc., Caledonia, MI, United States |
| Recall initiated | 2014-03-20 |
| Classified | 2014-04-07 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2014-11-25 |
| Distributed | AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WV, WY |
| Countries outside the US | AE, BE, CA, CR, EC, GB, IT |
| Reason classes | sterility |
Product
7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1423-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.