Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
This recall is currently active, issued October 23, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- September 4, 2024
- Posted
- October 23, 2024
- Recall Number
- Z-0153-2025
- Quantity
- 320 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Lot / Code Info
a) DYNJ80370A, UDI/DI 40195327388547 (each), 10195327388546 (case), Lot Numbers: 23LBM330; b) DYNJRA1854A, UDI/DI 40195327117062 (each), 10195327117061 (case), Lot Numbers: 23LBJ089
Root Cause
Under Investigation by firm
Action Taken
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.