Recall Z-2577-2021

Reason for recall

There is a potential for distal end of catheters to fracture and become detached.

FDA-determined cause: Under Investigation by firm

Action taken

On August 18, 2021 , Imperative Care issued a "Urgent: Voluntary Medical Device Recall" Notification to all affected healthcare facilities. In addition to informing consignees about the recalled product, Imperative Care ask consignees to take the following actions: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific lot numbers listed within the recall notification . 3. Remove and quarantine all unused affected products in your inventory. 4. Return the potentially affected products to Imperative Care. Your local Imperative Care Sales Representative can assist in facilitating the return of product as necessary. 5. If replacement product is needed, your Imperative Care Sales Representative can assist you with identifying suitable replacement product. 6. Complete the attached Customer Confirmation Certificate and contact your local Imperative Care Sales Representative. 7. Please ensure that the attached Customer Acknowledgement Certificate is returned within 3 business days to acknowledge receipt within your Department/Facility. This may be a requirement within your healthcare organization. 8. If you have any questions regarding this voluntary recall, please contact Imperative Care Customer Service at 1-408-502-7548, your Imperative Care Sales Representative, or email us at return@imperativecare.com. 9. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.