Reported Dec 17, 2014 · Terminated
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by…
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?
- Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published — Schoitz Weights 7.5 grams 720-55812Instrumed — Trade Name: Ambler Surgical — Ambler Surgical Product Name: Schoitz Weights 7.5 grams 5754BAmbler Surgical — Lot Number: 050411. 2) Instrumed Product Name: Schoitz Weights 15.0 grams 720-55822Instrumed — Trade Name: Ambler Surgical — Ambler Surgical Product Name: Schoitz Weights 15.0 grams 5754FAmbler Surgical — Lot Number: 050411. - Amount recalled
- 3 Schoitz weights
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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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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