FDA (Devices) recall action 70985
The FDA (Devices) publishes a recall like this one as 62 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 62 pages.
Catheters may not meet antimicrobial specification
The agency’s own wording, quoted from the enforcement report.
The FDA is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units distributed worldwide.
The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 units internationally.
Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs because they may not meet antimicrobial specifications.
FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
FDA Class II recall of Palindrome SI Chronic Catheter Kits by Covidien LLC because the devices may not meet antimicrobial specifications.
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.