Z-1078-2023 Class II Ongoing
FDA device recall Z-1078-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 17, 2022 and is designated Class II. Reason for recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. The recall status is ongoing. Affected quantity: 2.542 cases (6,739 units).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Nov 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2.542 cases (6,739 units)
Product Description
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 for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1078-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026