Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF DYNJ57895; h) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803; i) BREAST PACK, REF DYNJ64376; j) CSTM PK SURGISTART MAINE PLAST, REF DYNJ66619A; k) PLASTIC PACK, REF DYNJ68030; l) CUSTOM PLASTIC PACK, REF DYNJ68062; m) PLASTIC LIMB SJHC-LF, REF DYNJ84997
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-0165-2025
- Quantity
- 1048 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) DYNJ42735A, UDI/DI 40888277226433 (each), 10888277226432 (case), Lot Numbers: 23LBP975; b) DYNJ43457, UDI/DI 40888277055309 (each), 10888277055308 (case), Lot Numbers: 23LBS052; c) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 24ABF270; d) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 23LBO013; e) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 24ABC805; f) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 23LBN742; g) DYNJ57895, UDI/DI 40889942790372 (each), 10889942790371 (case), Lot Numbers: 23KBF265; h) DYNJ62803, UDI/DI 40193489688994 (each), 10193489688993 (case), Lot Numbers: 23LBN303; i) DYNJ64376, UDI/DI 40193489807845 (each), 10193489807844 (case), Lot Numbers: 24ABD094; j) DYNJ66619A, UDI/DI 40195327427840 (each), 10195327427849 (case), Lot Numbers: 23LBU414; k) DYNJ68030, UDI/DI 40193489469289 (each), 10193489469288 (case), Lot Numbers: 23LBL117; l) DYNJ68062, UDI/DI 40193489474580 (each), 10193489474589 (case), Lot Numbers: 24ABC304; m) DYNJ84997, UDI/DI 40195327444212 (each), 10195327444211 (case), Lot Numbers: 23LBK468
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.