Field Safety Notice Teleflex Arrow® Kits and Sets with Introducer Needles Multiple Products (ICN 1628)

Important Customer Notice Field Safety Notice

Ref: 2022/1628 ICN Number: 1628

Alert: 

  • Teleflex has issued an Advisory Field Safety Notice for Arrow® Kits and Sets with Introducer Needles.
  • Teleflex has received complaints reporting that the introducer needle hub in some Arrow® kits crack under stress during the catheterization procedure.
  • Teleflex has identified four clinical practices (as noted on page one in the Field Safety Notice), that combined with a lack of adequate drying time, may overexpose the needle hub to alcohol-based antiseptic solutions such as Chlorhexidine based antiseptic / octenidine solution.
  • If the needle hub is saturated with an antiseptic solution it may weaken.
  • A weakened needle hub combined with the standard insertion method which requires pressure to be placed on the needle may result in a cracked needle hub.
  • If a cracked needle hub is not detected prior to use, the clinician may experience false signs of a possible insertion related pneumothorax. In addition, the clinician may not be able to aspirate a flashback of blood during needle introduction.

Products Affected:

  • There are 150 affected products available, or previously available, from NHS Supply Chain.
  • Please see our Downloads ▼ section to refer to the attached Product Listing and Field Safety Notice for information on the products affected.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Teleflex does not recommend use of an alcohol-based antiseptic solution in place of an approved ultrasound gel for invasive procedures.
  • Additionally, Teleflex advises following good clinical practice for skin antisepsis, which includes sufficient dry time (i.e., three minutes or more) for the skin antisepsis prior to needle insertion.
  • Complete the Acknowledgement Form (found on page three of the notice) and return the form to orders.uk@teleflex.com.
  • If you have any clinical education or product support questions, please direct these to Clinical.affairs.emea@teleflex.com .

If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

Downloads ▼

  • 1628 Teleflex Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1628.
  • 1628 Teleflex Product Listing

    An Excel file detailing the affected product codes for ICN 1628.
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