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
- Recall Initiated
- November 17, 2022
- Posted
- February 6, 2023
- Recall Number
- Z-1078-2023
- Quantity
- 2.542 cases (6,739 units)
- Firm Location
- Northfield, IL
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
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.