Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18830 |
| Brand Name: | Medline Custom Procedure Kit, incorporating Unomedical suction tubing |
| Model: | SOTNZAH04B |
| Affected: | CS1405587, CS1417569, CS1418438, CS1418710, CS1419278, CS1420864, CS1422092, CS1423500, CS1423501, CS1423955, CS1527665, CS1528112, CS1528978, CS1529680, CS1529789, CS1531866 |
| Software version: | |
| Recalling Organisation: | Paragon Care Group New Zealand Limited 69 Elizabeth Knox Place Glen Innes AUCKLAND |
| Contact Information: | 0508 654 258 |
| Manufacturer: | Medline Assembly Australia Pty Ltd |
| Issue: | Medline is recalling specified lots of the Unomedical Suction tubing. This tubing is a component in the Medline procedure pack product code SOTNZAH04B. An internal assessment of ConvaTec's product complaints confirmed that these devices were not meeting customer expectations. The connector parts for application to the suction device in these lots have failed to meet their required reliability. The connector parts of the specified lots have a higher probability to crack once applied to suction device outlets. Cracking may result in loss of suction during an operation. This could result in reduced surgical site visibility (due to poor removal of fluid) and may make stemming of bleeding more difficult. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/7/2015 |
