ICU Medical Ltd Spinning Spiros Male Luer Leaks (ICN 1117)

Important Customer Notice Recall

Ref: 2020/1117 ICN Number: 1117

MHRA 2020/009/004/701/026
Recall Ref: 41

Alert:

  • ICU Medical has identified the potential for certain lots of the Spinning Spiros to exhibit small amounts of leaks due to manufacturing variability.
  • Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, or fluid path air-in-line. ICU Medical has received reports of leaks potentially related to this issue and has not received reports of permanent injury or death.
  • This information pertains to the spinning version of the Spiros only. The non-spinning version is not affected by this communication.

Products Affected:

  • There are four products available from NHS Supply Chain affected by this Field Safety Notice, please refer to the product listing for full details. See our Downloads ▼ section
NPC Product description Supplier Code/MPC Route
FSB1277 Spinning Spiros® Closed Male Luer, Red Cap CH2000S-C Stock
FSB1278 5″ (13 cm) Bag Spike Adapter w/Spiros™ w/Red Cap, Vented Cap CH3034 Stock
FSB1240 Administration Set for Plum A plus Infusion Pump 44H323501 Stock
FSB2319 76 cm (30″) Admin Set, 2 Spiros® w/Red Cap, 20 Drop In-Line Drip
Chamber w/15 Micron Filter, Bag Hanger
011-CH3261 eDirect
  • Please note only the lot numbers listed in table 1 page 3 of this notice are affected.

Next Steps:

  • Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.
  • Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the e-mail address on the form, even if you do not have the affected product.
  • ICU Medical has some lots of unaffected product available today and is actively increasing the amount of available inventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLock CSTD as alternatives. Please contact ICU Medical customer service for product availability.
  • We are working with the supplier to identify suitable indirect alternatives.
  • Where affected product/ lot numbers are identified, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall). All products to be returned no later than Friday 2nd October 2020.

Please confirm if the quantity of product to be returned is singles or packs in the unit of issue.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Downloads ▼

  • 1117 ICU Medical Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1117.
  • 1117 ICU Medical Product Listing

    An Excel file detailing the affected product codes for ICN 1117.

    Please to view this content.