Z-0176-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- September 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 units
Product Description
Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
Reason for Recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Code Information
a) REF DYNJ46730, UDI/DI 40888277597199 (each), 10888277597198 (case), Lot Numbers: 23LBP056; b) REF DYNJ49302A, UDI/DI 40888277843395 (each), 10888277843394 (case), Lot Numbers: 24ABG706; c) REF DYNJ57526A, UDI/DI 40193489630931 (each), 10193489630930 (case), Lot Numbers: 23LBL679; d) REF DYNJ68750, UDI/DI 40193489836586 (each), 10193489836585 (case), Lot Numbers: 24ABB984