CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-76…
ICU Medical, Inc. · Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under deliver…
Open FDA's page for this record- Cfres ID
- 222072
- Product res number
- Z-3212-2026
- Event date initiated
- 2026-08-20
- Event date posted
- 2026-09-17
- Recall status
- Open, Classified
- Res event number
- 99648
- Product code
- LHI
- Firm FEI number
- 3013319212
- Recalling firm
- ICU Medical, Inc.
- Address 1
- 600 N Field Dr
- City
- Lake Forest
- State
- IL
- Postal code
- 60045-4835
- Additional info contact
- Customer Service 800-258-5361
- Root cause description
- Process control
- Product quantity
- 185,688 units
- Product description
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP 21-7600-24JP 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24
- Code info
21-7600-24 UDI-DI 30610586044001 Lots 6026878 6037784 6054015 6062724 6070616 6082332 6092886 6101906 6108556 6126029 6140893 6143454 6147696 6147697 6162769 6155095 6166032 6171587 6171586 21-7609-24 UDI-DI 30610586044018 Lot 6022079 6037697 6037698 6053978 6061525 6072970 6072964 6070575 6077773 6092846 6101798 6108514 6108515 6108516 6140862 6140861 6140865 6155132
- Reason for recall
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
- Action
On August 20, 2026, the firm began notifying affected customers via Urgent Medical Device Correction letters. Customers were informed that certain reservoirs may exhibit fluid leakage at the joint between the connector and the tubing. Customers were instructed to check all inventory locations for affected product and discontinue use. All affected products should be destroyed following their institution's destruction process. If destruction is not immediately possible at your facility, quarantine the products until disposal. Customers should share the notification with all potential users of the reservoirs, and notify any accounts to whom the affected products have been further distributed. The firm will provide replacement products to affected customers upon receipt of a completed Customer Response Form to certify product destruction.
- Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS, TN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden.
- K numbers
- K162219
- Harmonized identifiers (openFDA)
- Device name
- Set, I.V. Fluid Transfer
- Medical specialty description
- General Hospital
- Regulation number
- 880.5440
- Device class
- 2
- K number
- K232875, K231071, K974198, K852467, K850051, K812928, K151423, K842345, K243486, K190149, K853188, K902482, K132863, K072511, K983794, K921031, K131646, K013523, K955896, K024239, K140442, K092246, K212530, K853075, K203674, K903159, K910793, K921365, K042410, K162216, K001368, K233021, K060866, K961008, K252987, K943095, K832332, K950305, K980587, K122265 +166 more
- Registration number
- 1417592, 3022555290, 3003704957, 3003678543, 9617604, 3014312726, 9681240, 3030626857, 3012798826, 2245590, 1314417, 1420088, 1835568, 3033527281, 2029275, 3004548776, 9610825, 3000279201, 1416980, 3006610642, 1643817, 1048735, 3003152976, 3014342658, 1319660, 1450662, 3016418550, 3027645738, 2520313, 2032098, 1055927, 3004201393, 3043226252, 3010291427, 3007143236, 3007829657, 3030446844, 1713468, 3006571738, 1424263 +136 more
- FEI number
- 1417592, 3022555290, 3003704957, 3003678543, 3014312726, 3030626857, 3012798826, 2245590, 1314417, 1420088, 3033527281, 3000215205, 3004548776, 3002807880, 3003807466, 3000279201, 3000147578, 1416980, 3006610642, 1643817, 1048735, 3002808169, 3003152976, 3014342658, 1000518731, 1450662, 3016418550, 3027645738, 2520313, 3008002452, 3004201393, 3043226252, 3000327333, 3010291427, 3007143236, 3007829657, 3030446844, 1000512168, 1713468, 3006571738 +136 more