Recall archive / FDA device enforcement
Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17... — FDA record Z-0177-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PACK, REF DYNJ42884; h) RFT D & C PACK, REF DYNJ50851; i) KIT OB, REF DYNJ906623; j) D AND C, REF DYNJ907957A; k) CHS OB PACK III, REF DYNJCH907
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1506 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0177-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) REF DYNJ0912449M, UDI/DI 40889942437536 (each), 10889942437535 (case), Lot Numbers: 23LBP185; b) REF DYNJ17309G, UDI/DI 40193489277181 (each), 10193489277180 (case), Lot Numbers: 24ABB399; c) REF DYNJ34268D, UDI/DI 40193489821421 (each), 10193489821420 (case), Lot Numbers: 23LBM844; d) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23LBS099; e) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23KBB869; f) REF DYNJ39668I, UDI/DI 40195327456284 (each), 10195327456283 (case), Lot Numbers: 23LBM868; g) REF DYNJ42884, UDI/DI 40888277011077 (each), 10888277011076 (case), Lot Numbers: 23KBB574; h) REF DYNJ50851, UDI/DI 40889942029014 (each), 10889942029013 (case), Lot Numbers: 23LBL975; i) REF DYNJ906623, UDI/DI 40193489794695 (each), 10193489794694 (case), Lot Numbers: 24ABE587; j) REF DYNJ907957A, UDI/DI 40195327189854 (each), 10195327189853 (case), Lot Numbers: 24BBA954; k) REF DYNJCH907, UDI/DI 40193489391979 (each), 10193489391978 (case), Lot Numbers: 24ABC904 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 30, 2024
- Recall initiation date
- Sep 4, 2024
- Center classification date
- Oct 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.