ICU Medical, Inc. 2022-09-14 Health serious FDA
Health · FDA · Recall #FDA-Z-1681-2022
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/… Recall
Issued September 14, 2022 · ICU Medical, Inc.
In September 2022, ICU Medical, Inc. recalled the Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ICU Medical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ICU Medical, Inc.
- Category
- Health
- Recall date
- September 14, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, A
- Recall number
- FDA-Z-1681-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- ICU Medical, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.