Tonometers are manual devices intended to measure recall
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of…
Why was Tonometers are manual devices intended to measure 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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 Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Schoitz Tonometer; Millennium Surgical Item Number: 3-5754; Lot Number: 030212. 2) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Schoitz Tonometer; Symmetry Surgical Item Number: 60-6031; Lot Numbers: 030212, 030413, 040113, 100312, 120113. 3) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Accutome; Accutome Product Name: Schoitz Tonometer; Accutome Item Number: AM0530; Lot Number: 030212, 120113. 4) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Boss Instruments; Boss Instruments Product Name: Schoitz Tonometer; Boss Instruments Item Number: 80-9010; Lot Number: 100312. 5) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Medline Industries; Medline Industries Product Name: Tonometer, Eye, Schiotz, w/ 3 Weights, Case; Medline Industries Item Number: MDG0781649; Lot Number: 030212, 040113, 100312, 120113.
- Product
- Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of…
- Recalling firm
- Instrumed International, Inc.
- Quantity
- 23 tonometers
- 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)