Recall archive / FDA device enforcement
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION ... — FDA record Z-1128-2023
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 Dec 7, 2022. 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
- Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177; e) CENTURION MEDICAL PRODUCTS LUMBAR PUNCTURE KIT, Reorder Number PT235A
- Reason
- The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 4779 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1128-2023
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) Reorder Number DYNJ67850, GTIN 10193489445541, Lot # 22BBJ239; b) Reorder Number DYNJSHOULDER2, GTIN 10884389097458, Lot # 22DBN344; c) Reorder Number P429589A, GTIN 40889942436348, Lot # 22HME367; d) Reorder Number SPEC0177, GTIN 40884389914657, Lot # 22MBA770; e) Reorder Number PT235A, GTIN 40653160992746, Lot # 22HMH321 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide
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
- Feb 22, 2023
- Recall initiation date
- Dec 7, 2022
- Center classification date
- Feb 10, 2023
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.