Z-1095-2019Class I

icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented...

Name: Z-1095-2019 icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented...
Creator: ICU Medical, Inc.
Published: 2019-02-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-02-21 / Terminated / root cause: supplier

FDA source

ICU Medical, Inc. began a recall of icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike... on 2019-02-21. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1095-2019
Classification: Class I
Status: Terminated
Initiated: 2019-02-21
Posted: 2019-04-15
Terminated: 2024-06-04
Recalling firm: Abbott Medical
Product: icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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 tag: supplier
FDA 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: [email protected], even if you do not have the affected product. 3) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.com to request additional labels for returning affected product. 4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) to obtain a response form. UPDATED INFORMATION: On 03 January 2019, ICU Medical, Inc. issued an Urgent Medical Device Recall letter informing customers of a recall of one lot (3757712) of the ChemoLock" Vial Spike, 20mm (CL-80S). As a result of continued evaluation, ICU Medical is expanding the scope of the previously distributed Urgent Medical Device Recall to include certain lots of ChemoLock" and ChemoClave Vial Spikes that may also be affected by this issue. All product lots identified in this communication are impacted by this recall. If you have any questions, please contact Customer Care at 1- 877-946-7747 General inquires /Product replacement options.
Quantity in commerce: 300 devices
Distribution: Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
Product codes and lots: Lot Numbers: 3846116, 3855565

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1092-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15
Z-1093-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15
Z-1094-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15
Z-1095-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15
Z-1096-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15
Z-1097-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15
Z-1098-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)