Device product
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
Z-1073-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 237 cases (1,242 units)
- Official record key
device-enforcement:Z-1073-2023
Official wording
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Code information: 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
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Derived failure modes
-
Unknown
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.