Reported Apr 16, 2014 · Terminated
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed…
Aspen Surgical Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aspen Surgical Products, Inc. · 6945 Southbelt Dr Se · Caledonia, MI · 49316-7664
Is this the product you have?
- 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
- Lot codes and dates
- Product Number 340019
- Amount recalled
- N/A
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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