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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter EXACTAMIX Inlet, Syringe Inlet

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 Class 2 Device Recall Baxter EXACTAMIX Inlet, Syringe Inletsee related information
Date Initiated by FirmApril 25, 2018
Create DateMay 22, 2018
Recall Status1 Terminated 3 on December 16, 2020
Recall NumberZ-1911-2018
Recall Event ID 79975
510(K)NumberK002705 
Product Classification Set, i.V. Fluid transfer - Product Code LHI
ProductBaxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 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: 00085412475813 Lot numbers: 802284, 802285, 802286
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter 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
ActionThe 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 Commerce112975 units
DistributionWorldwide Distribution - US Distribution
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.
510(K) Database510(K)s with Product Code = LHI
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