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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter EXACTAMIX Inlet, Vented, HighVolume Inlet

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  Class 2 Device Recall Baxter EXACTAMIX Inlet, Vented, HighVolume Inlet see related information
Date Initiated by Firm April 25, 2018
Create Date May 22, 2018
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-1909-2018
Recall Event ID 79975
510(K)Number K002705  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174

Usage:
Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Code Information UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Paxter
800-422-9837
Manufacturer Reason
for Recall		 Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
FDA Determined
Cause 2		 Labeling Change Control
Action The firm initiated the recall by letter on 04/25/2018. The letter identified the affected product, problem and actions to be taken. the firm requested the return of the product. Distributors were directed to conduct a sub-recall, requesting their customers return the product to the entity from whom they received the product.
Quantity in Commerce 59475 units
Distribution Worldwide Distribution - US Distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = BAXA CORP.
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