Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusi

FDA device recall Z-1319-2022 · posted 2022-07-07 · Open, Classified

Recall details

Recalling firm

Covidien Llc

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Action taken

Medtronic distributed a recall notification to customers by mail on 06/08/2022. Customers were instructed to immediately quarantine and discontinue use for specific lots of chronic hemodialysis catheters, which are to be returned to Medtronic. If customers have further distributed product, they are asked to forward the information from the recall notification to those recipients. All customers are asked to complete and return the Consignee Product Retrieval Confirmation Form to rs.gmbfcamitg@medtronic.com. Additionally, consignees are asked to share the notice within their organization and retain it for their records regarding the retrieval of unused product. If a consignee is aware of any adverse events associated with recalled product, they are to submit a report to FDA via Medwatch. Customers with any questions can contact their Medtronic Representative or call Customer Service at 800-962-9888, option 2. ***Updated 8/16/22*** Medtronic has created a website to help customers identify affected product: https://www.medtronic.com/covidien/en-us/products/c/renal-care-recall-lookup-tool.html#lotLookupTool

Root cause

Process control

Status

Open, Classified

Product code

MSD

Quantity affected

13,526 units

Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV,

Date initiated

2022-06-08

Date posted

2022-07-07

Location

Mansfield, MA

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