Z-2527-2025Class II
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop...
Abbott Medical / initiated 2025-08-06 / Open, Classified / root cause: manufacturing process
ICU Medical Inc. began a recall of Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2527-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Abbott Medical
- 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
- Product code
- FPA Set, Administration, Intravascular
- 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.
- Root cause tag
- manufacturing process
- FDA 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 [email protected] 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 [email protected]. For further inquires: - To report adverse events or product complaints: Global Complaint Management: [email protected]; 1-(866)-216-8806 - Additional information or to request replacement product: Customer Service: [email protected]; 1-(800)-258-5361 - Questions about this communication: Field Action Processing: [email protected]; 1-(844)-861-6220
- Quantity in commerce
- 15546 units
- Distribution
- Worldwide distribution.
- Product codes and lots
- UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2522-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2523-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2524-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2525-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2526-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2527-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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