| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00882-1 |
| Product Name/Description |
General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile)
General Laparoscopy Procedure Pack
Product Codes: CSBABRMQ18A and CSBABRMQ18B
Gynecological Laparoscopy Procedure Pack
Product Codes: CSMABRMQ10A and CSMABRMQ10B
ARTG Number: 137395 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
This letter is to inform users that Medline is recalling two procedure packs, the General Laparoscopy and the Gynecological Laparoscopy, as they contain a ConMed CORE Suction Irrigation Handpiece. Medline was informed by ConMed that the CORE Suction Irrigation Handpiece may contain creases in the packaging seal which sometimes results in an open channel. These channels may compromise sterility of the product. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medline is advising users to check the procedure packs in stock, remove and retain the ConMed CORE suction Irrigation Handpiece for return. Medline will replace the affected handpieces with unaffected stock.
This action has been closed-out on 20/01/2017. |
| Contact Information |
1800 110 511 - Medline Customer Service Team |