Reported Sep 14, 2022 · Ongoing
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
18 of 18 products
| # | Product as published |
|---|---|
| 1 | Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S |
| 2 | ChemoLock Bag Spike/CL-10 |
| 3 | ChemoLock w/Mini Bag Spike/CL-17 |
| 4 | 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950 |
| 5 | 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951 |
| 6 | 5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967 |
| 7 | 6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL4118 |
| 8 | ChemoLock Kit w/ 5" (13 cm) Bag Spike Adapter w/ChemoLock w/Red Cap, Vented Cap, ChemoLock Port Bag Spike/CL4158 |
| 9 | ChemosafeLock Bag Spike/KL-BS001U3 |
| 10 | ChemosafeLock Vial Adapter/KL-VA201U3 |
| 11 | ChemosafeLock Vial Adapter/KL-VA202U3 |
| 12 | ChemosafeLock Vial Adapter/KL-VA321U3 |
| 13 | ChemosafeLock Vial Adapter/KL-VA322U3 |
| 14 | ChemoLock Vented Vial Spike/011-CL-51 |
| 15 | Transfer Set, PUR Yellow w/ChemoLock Port, Spiros/011-CL4155 |
| 16 | Puerto ChemoLock/034-CL2100 |
| 17 | ChemoLock, Punzon Univ. Vial c/ Filtro, fijacion/034-CL-70 |
| 18 | ChemoLock, Punzon Vial Tritan c/ Filtro, 13mm/034-CL-72 |
- Lot codes and dates
17 of 17 products
Products covered by this recall # Product as published 1 011-CL-80S/5843950 2 CL-10/5850516 3 CL-17/5816314, 5829878, 5842209, 5850503 4 CL3950/5845117, 5885020 5 CL3951/5842199, 5872831 6 CL3967/5829901, 5842210 7 CL4118/5825274, 5872840 8 KL-BS001U3/5851020, 5851021, 5851022, 5910255, 5910258 9 KL-VA201U3/5819364 10 KL-VA202U3/5819370, 5910262 11 KL-VA321U3/5915973 12 KL-VA322U3/5920744 13 011-CL-51/5850505 14 011-CL4155/5816324 15 034-CL2100/5842230 16 034-CL-70/5816321 17 034-CL-72/5816344 - Amount recalled
- 358,975
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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