Recall Z-1098-2019 · FPA Set, Administration, Intravascular

ICU Medical, Inc.

SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administrat

Date	Apr 15, 2019 (initiated Feb 21, 2019)
Status	Terminated
Reason	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.
Root cause	Vendor change control
Action	The firm, Icumedical, initiated the recall by "URGENT: MEDICAL DEVICE RECALL" letter on 02/21/2019 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form via fax to: 1-855-497-9856 or email to: ICUMedical6834@stericycle.com, even if y
Quantity	3500 units
Distribution	Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.