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U.S. Department of Health and Human Services

Class 1 Device Recall Scrip

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  Class 1 Device Recall Scrip see related information
Date Initiated by Firm August 18, 2021
Create Date November 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-0225-2022
Recall Event ID 88751
510(K)Number K962840  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Code Information Item Number: 663 0019, all lots distributed between August 2018 and August 2021
Recalling Firm/
Manufacturer		 Scrip Inc
9005 N Industrial Rd
Peoria IL 61615-1511
For Additional Information Contact Customer Service
800-747-3488
Manufacturer Reason
for Recall		 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
FDA Determined
Cause 2		 Process control
Action The recalling firm, allegromedical, issued "URGENT Action Required" correspondence on or around 10/12/2021 informing customers of the recall and to stop use of the product. If product was further distributed, customers are asked to notify additional recipients of the product recall. If you have any questions, contact VP of Operation at 630-771-7410 or email: lpantera@scripco.com.
Quantity in Commerce 1001 gallons
Distribution US Nationwide Distribution to all 50 states.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = ECO-MED PHARMACEUTICALS, INC.
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