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
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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 |
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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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510(K) Database | 510(K)s with Product Code = LHI
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