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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical

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 Class 2 Device Recall Smiths Medicalsee related information
Date Initiated by FirmAugust 06, 2025
Date PostedSeptember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2522-2025
Recall Event ID 97317
510(K)NumberK040636 
Product Classification Set, administration, intravascular - Product Code FPA
ProductSmiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Code Information UDI/DI 10610586022111, Lot Numbers: 6022008, 6022009, 6037749, 6062686, 6062687
FEI Number 3012307300
Recalling Firm/
Manufacturer		 ICU Medical Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactCustomer Service
800-258-5361
Manufacturer Reason
for Recall		Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
FDA Determined
Cause 2		Under Investigation by firm
ActionICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 08/06/2025 via registered mail and email. The notice explained the issue, potential risk can requested the following: Customer Required Actions: Please complete the following actions below. 1. Review your inventory of CADD Medication Cassette Reservoirs to confirm if any of the affected lots are within your possession. 2. Quarantine the affected product and destroy or discard it immediately following your institution s process for destruction or discarding. 3. Return the attached Customer Response Form to ICUMedical8176@sedgwick.com within ten (10) days of receipt to acknowledge your understanding of this notification. 4. DISTRIBUTORS: Immediately forward this notice to all users to whom you distributed these products. Request that they complete the Customer Response Form and return it to ICUMedical8176@sedgwick.com. For further inquires: - To report adverse events or product complaints: Global Complaint Management: productcomplaints@icumed.com; 1-(866)-216-8806 - Additional information or to request replacement product: Customer Service: customerservice@icumed.com; 1-(800)-258-5361 - Questions about this communication: Field Action Processing: ICUMedical8176@sedgwick.com; 1-(844)-861-6220
Quantity in Commerce29811 units
DistributionWorldwide 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 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) Database510(K)s with Product Code = FPA
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