FDAClass IMarch 6, 2019

icumedical ChemoLock Vial Spike recall: Particulate Matter

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental…

Why was icumedical ChemoLock Vial Spike recalled?

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

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?

Lot Number 3757712

Product
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental…
Recalling firm
ICU Medical, Inc.
Quantity
2050 units
Distribution
US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.
Recall date
March 6, 2019
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls