Reported Dec 17, 2014 · Terminated
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the…
Instrumed International, 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: Instrumed International, Inc. · 626 Cooper Ct · Schaumburg, IL · 60173-4537
Is this the product you have?
- A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
- Lot codes and dates
41 of 41 products
Products covered by this recall Model / number Product as published — Zipser Meatus Clamp 4 1/4" 330-86112Instrumed — Trade Name: Medline Industries — Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4 MDG5597111Medline Industries — Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4" 330-86112Instrumed — Trade Name: Boss Instruments — Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4" 46-5195Boss Instruments — Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4" 330-86112Instrumed — Trade Name: Millennium Surgical — Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4" 9-124570Millennium Surgical — Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4" 330-86112Instrumed — Trade Name: Medetz Surgical Instruments — Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4" 9-124570Medetz Surgical Instruments - Amount recalled
- 81 clamps
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
Why it was recalled
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
This product could cause temporary or reversible health problems — stop using it.
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