icumedical ChemoLock recall: Particulate Matter
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer…
Why was icumedical ChemoLock recalled?
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(a) REF CL,-80S, Lot numbers: 3824204, 3824209, 3826652, 3828646, 3829557, 3836196, 3836811, 3853995, 3853997, 3866764, 3866766, 3872065, 3872072, 3872085, 3872093, 3872433, 3872444, 3910642, 3920773, 3932270, 3945868, 3946776 (b) REF CL-80S-10 (10 units), Lot Numbers: 3820519, 3820522, 3839240, 3839241, 3844783, 3844784, 3854004, 3854005, 3910656, 3932907, 3946771, 3946772
- Product
- icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer…
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 160775 devices
- Distribution
- Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
- Recall date
- April 24, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)