Z-1073-2023Class II
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
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. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF 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-1073-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
- Product code
- FCH Tray, Biopsy, Without Biopsy Instruments
- 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
- 237 cases (1,242 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Product codes and lots
- a. MINOR/BREAST BIOPSY-LF, Item Number: DYNJS3035, Case UDI/GTIN: 40884389421926, Unit UDI/GTIN: 10884389421925, Lot Number: 22IBK248,22IBB171,22HBM446; b. BREAST BIOPSY-LF, Item Number: DYNJT1911D, Case UDI/GTIN: 40888277808967, Unit UDI/GTIN: 10888277808966, Lot Number: 22JBG862,22HBV267
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 |
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