Z-1078-2023Class II
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-11-17 / Open, Classified / root cause: design
MEDLINE INDUSTRIES, LP - Northfield began a recall of 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... on . FDA classified it as Class II and gives the reason as "Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1078-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Product code
- KDD Kit, Surgical Instrument, Disposable
- Reason for recall
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- 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.
- Quantity in commerce
- 2.542 cases (6,739 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1060-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1061-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1062-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1063-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1064-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1065-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1066-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1067-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1068-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1069-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1070-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1071-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1072-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1073-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1074-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1075-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1076-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1077-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1078-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1079-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1080-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1081-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1082-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1083-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1084-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1085-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1086-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1087-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1088-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1089-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1090-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1091-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1092-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1093-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1094-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1095-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1096-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1097-2023 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.