| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00407-1 |
| Product Name/Description |
MONOCRYL (poliglecaprone 25) Suture and MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture
MONOCRYL PLUS VIO 70CM 3-0 S/A UR-7
Product code: MCP604H
Lot number: UAMLQE
ARTG: 281506
MCRYL UD 70CM 4-0 S/A PS-1 PRM MP
Product code: Y935H
Lot number: UBMCAA
ARTG: 176699 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
Ethicon identified a manufacturing problem with a specific packaging machine that resulted in a hole in the primary packaging of a small percentage of MONOCRYL and MONOCRYL Plus sutures manufactured between January 27 and March 27, 2024.
The occurrence of this defect is rare with an estimated rate of 0.011% of product presenting the condition.
Ethicon has not received any complaints or reports of injuries related to this problem.
If the defect is not detected, the breach in sterility could introduce pathogens to the patient and cause infection.
A hole in the cavity also exposes the product to the environment which could potentially compromise its physical properties leading to treatment failure which may require additional surgical intervention or prolonged surgery. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers must:
Immediately inspect the device(s) in their possession to determine if their facility has affected product. If so, they are to quarantine this product and contact Johnson & Johnson Medical for an immediate return and refund.
Health care practitioners who have treated patients using these product lots should follow those patients post-operatively in the usual manner with no additional action required. |
| Contact Information |
1800 252 194 - Johnson & Johnson Customer service |