Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19162
Brand Name:Arrow 4Fr Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)
Model:PR-05041-HP, CA-05041-HP
Affected:All lots
Software version:
Recalling Organisation:InterMed Medical Ltd
71 Apollo Drive
Albany
AUCKLAND 1311
Contact Information:0800 333 444
Manufacturer:Arrow International Inc
Issue:There is a labelling inaccuracy in the Instructions for Use (IFU) and injection card. The IFU and the injection card contained within the product states that PICC testing included 10 pressure injection cycles. This is not correct, it should state that catheter testing included 5 pressure injection cycles.
If it were to be used for more than five (5) pressure injections, it cannot be ruled out that there is a potential risk that the catheter could rupture during injections 6-10. Catheter rupture can cause catheter or air embolism, bleeding or ineffective treatment and may require the need for radiologic or surgical intervention. No customer complaints have been received for this issue.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/10/2015
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