Schoitz weights are manual devices used with Schoitz recall
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the…
Why was Schoitz weights are manual devices used with Schoitz 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Instrumed Product Name: Schoitz Weights 7.5 grams; Instrumed Product Number: 720-55812; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 7.5 grams; Ambler Surgical Item Number: 5754B; Lot Number: 050411. 2) Instrumed Product Name: Schoitz Weights 15.0 grams; Instrumed Product Number: 720-55822; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 15.0 grams; Ambler Surgical Item Number: 5754F; Lot Number: 050411.
- Product
- Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the…
- Recalling firm
- Instrumed International, Inc.
- Quantity
- 3 Schoitz weights
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)