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Recall Observatory FDA recall evidence

Device product

Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK

Z-1080-2023

November 17, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 91386
Status
Ongoing
Classification
Class II
Quantity
26 cases (104 units)
Official record key
device-enforcement:Z-1080-2023

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. UNIVERSAL PLASTIC, Item Number: DYNJ04047C, Case UDI/GTIN: 40888277855060, Unit UDI/GTIN: 10888277855069, Lot Number: 22IBH860,22IBJ054; b. KNEE ARTHROSCOPY PACK, Item Number: DYNJ24784C, Case UDI/GTIN: 40889942732587, Unit UDI/GTIN: 10889942732586, Lot Number: 22JBM001;

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.