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Recall Observatory FDA recall evidence

Device product

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

Z-0176-2025

September 04, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95415
Status
Ongoing
Classification
Class II
Quantity
88 units
Official record key
device-enforcement:Z-0176-2025

Official wording

Reason: 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.

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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile product if the vendor seal of the pouch is opened/unsealed