The Recall Desk

FDA (Devices) recall action 70985

Covidien LLC recalled 62 products on 2015-07-08

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.

Products
62
Announced
2015-07-08
Critical
0
Units

Why these products were recalled

Catheters may not meet antimicrobial specification

The agency’s own wording, quoted from the enforcement report.

26–50 of 62

  • HighFDA (Devices)··2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Defects

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Failure

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC 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.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    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.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues

    FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units distributed in the US and internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    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.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Covidien Recalls Chronic Catheters That May Not Meet Antimicrobial Specifications

    Covidien LLC is recalling specific lots of 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.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    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.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2015-07-08

    Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheter Kits

    FDA Class II recall of Palindrome Precision SI Chronic Catheter Kits due to potential failure to meet antimicrobial specifications.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-07-08

    Palindrome Precision HSI Chronic Catheter Recalled for Antimicrobial Specification Failure

    Covidien LLC 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.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2015-07-08

    Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC 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.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Defects

    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.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
    Category
    Distribution
    0 states