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Recall Observatory FDA recall evidence

Device product

Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

Z-1073-2023

November 17, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
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

    reason.no_named_rule · v1.0.0

    Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.