HD And Pd Disposables 35000 Iia Zurich

Recalling firm
Vantive Limited
Product
HD and PD disposables 35000 IIa Zurich. [Device]. Model: Transfer Set (MiniCap Extended Life PD Transfer Set with Twist Clamp), Transfer Set (MiniCap Extended Life PD Transfer Set with Twist Clamp – Extra Short), Transfer Set (MiniCap Extended Life PD Transfer Set with Twist Clamp – Extra Long). Affected: Product code - R5C4482, R5C4483, R5C4484
Reason
9/19/26: Update - The manufacturer has provided additional guidance and recommends continuing to use peroxide-cured silicone tubing sets. For patients under 6 months of age (approximately 3.5 kg), shorter transfer sets should be prioritised where platinum-cured silicone tubing or other alternatives are unavailable., Issue 1:, An increase in complaints has been reported involving separation of the female connector from the transfer set during connection or disconnection. The sterile fluid path remains intact, with no resulting risk of microbial contamination., Issue, 2:, The MiniCap...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-10-09
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/a76f3752-fdf2-44b2-a861-b475b23dff70