FDA Medical devices recall ·
Medline brand medical procedure convenience kits… recall
- Recall number
- Z-0165-2025
- Date
- (initiated September 4, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1048 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0165-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.