Recall archive / FDA device enforcement
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BA... — FDA record Z-1078-2023
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 Nov 17, 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
- Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN
- Reason
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 2.542 cases (6,739 units)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1078-2023
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. ST. ANNE'S MAJOR BASIN SET UP, Item Number: DYNJ24628M, Case UDI/GTIN: 40195327109135, Unit UDI/GTIN: 10195327109134, Lot Number: 22JLA323,22ILA590; b. SINGLE BASIN SET, Item Number: DYNJ35592K, Case UDI/GTIN: 40195327110827, Unit UDI/GTIN: 10195327110826, Lot Number: 22JBW819,22IBK206; c. DOUBLE BASIN SET, Item Number: DYNJ35596G, Case UDI/GTIN: 40195327110810, Unit UDI/GTIN: 10195327110819, Lot Number: 22JBH675,22HBY465; d. LAPAROTOMY BASIN, Item Number: DYNJ41354B, Case UDI/GTIN: 40195327246311, Unit UDI/GTIN: 10195327246310, Lot Number: 22JBE052; e. ORTHOPEDIC CUSTOM BASIN SET, Item Number: DYNJ47991J, Case UDI/GTIN: 40195327230600, Unit UDI/GTIN: 10195327230609, Lot Number: 22JBX225,22JBH710,22HBW917,22HBV171; f. OISC BASIN TRAY, Item Number: DYNJ48354I, Case UDI/GTIN: 40195327154302, Unit UDI/GTIN: 10195327154301, Lot Number: 22IMF862; g. BASIN PACK, Item Number: DYNJ50123D, Case UDI/GTIN: 40195327201990, Unit UDI/GTIN: 10195327201999, Lot Number: 22HBU014; h. BASIN SET, Item Number: DYNJ50906F, Case UDI/GTIN: 40195327140145, Unit UDI/GTIN: 10195327140144, Lot Number: 22JMB641,22HMD087; i. SURGI START PACK, Item Number: DYNJ52541D, Case UDI/GTIN: 40195327164509, Unit UDI/GTIN: 10195327164508, Lot Number: 22JBH137; j. PK, GEN-SET UP - MIDWEST, Item Number: DYNJ57608B, Case UDI/GTIN: 40195327253296, Unit UDI/GTIN: 10195327253295, Lot Number: 22JMB780; k. SINGLE BASIN PACK-LF, Item Number: DYNJ58389D, Case UDI/GTIN: 40195327144198, Unit UDI/GTIN: 10195327144197, Lot Number: 22GBW998; l. AGHM MINOR SINGLE PACK, Item Number: DYNJ62766B, Case UDI/GTIN: 40195327116775, Unit UDI/GTIN: 10195327116774, Lot Number: 22JMC641,22HMD203; m. MINOR PACK, Item Number: DYNJ63961B, Case UDI/GTIN: 40195327146970, Unit UDI/GTIN: 10195327146979, Lot Number: 22IDA519; n. SINGLE BASIN PACK, Item Number: DYNJ66012A, Case UDI/GTIN: 40195327221455, Unit UDI/GTIN: 10195327221454, Lot Number: 22JLA612,22ILA886,22HLA208; o. MAJOR BASIN PACK, Item Number: DYNJ69406A, Case UDI/GTIN: 40195327112333, Unit UDI/GTIN: 10195327112332, Lot Number: 22JMH995,22JMA882; p. BASIC SET UP-LF, Item Number: DYNJ81646, Case UDI/GTIN: 40195327130269, Unit UDI/GTIN: 10195327130268, Lot Number: 22IBH244; q. BASIC SET-UP-LF, Item Number: DYNJ82390, Case UDI/GTIN: 40195327189540, Unit UDI/GTIN: 10195327189549, Lot Number: 22JBV631,22IBC646; r. BASIN PACK, Item Number: DYNJ82969, Case UDI/GTIN: 40195327218325, Unit UDI/GTIN: 10195327218324, Lot Number: 22JBN923; s. MINOR BASIN, Item Number: DYNJ907808B, Case UDI/GTIN: 40195327244430, Unit UDI/GTIN: 10195327244439, Lot Number: 22JBU478,22JBA257,22IBV340,22IBS662; t. AMC MAJOR BASIN, Item Number: GSP158AA, Case UDI/GTIN: 40195327143511, Unit UDI/GTIN: 10195327143510, Lot Number: 22HBT951; u. AMC MAJOR BASIN, Item Number: GSP158AB, Case UDI/GTIN: 40195327252022, Unit UDI/GTIN: 10195327252021, Lot Number: 22JBD534 |
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, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
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 15, 2023
- Recall initiation date
- Nov 17, 2022
- Center classification date
- Feb 6, 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.