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U.S. Department of Health and Human Services

Class 2 Device Recall Ambler Surgical

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 Class 2 Device Recall Ambler Surgicalsee related information
Date Initiated by FirmSeptember 08, 2014
Date PostedDecember 16, 2014
Recall Status1 Terminated 3 on November 29, 2017
Recall NumberZ-0559-2015
Recall Event ID 69471
Product Classification Tonometer, manual - Product Code HKY
ProductSchoitz 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.
Code Information 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.
Recalling Firm/
Manufacturer
Instrumed International, Inc.
626 Cooper Ct
Schaumburg IL 60173-4537
For Additional Information ContactMs. Jennifer S. Staunton
847-908-6119
Manufacturer Reason
for Recall
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
FDA Determined
Cause 2
No Marketing Application
ActionInstrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
Quantity in Commerce3 Schoitz weights
DistributionNationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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