FDA Medical Device Recalls (openFDA)
ICU Medical Inc.: Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
- Recall number
- Z-2527-2025
- Recalling firm
- ICU Medical Inc.
- Product
- Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
- Status
- Open, Classified
- Initiated
- 2025-08-06
- Posted
- 2025-09-04
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- ICU 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
- 15546 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28