Skip to content
Recall Observatory FDA recall evidence

Device product

Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK

Z-1081-2023

November 17, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 91386
Status
Ongoing
Classification
Class II
Quantity
36 cases (116 units)
Official record key
device-enforcement:Z-1081-2023

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. WOUND CLOSURE TRAY, Item Number: DYNJ56703, Case UDI/GTIN: 40889942672418, Unit UDI/GTIN: 10889942672417, Lot Number: 22JBE355; b. WOUND PACK, Item Number: DYNJ80201A, Case UDI/GTIN: 40195327171538, Unit UDI/GTIN: 10195327171537, Lot Number: 22IBE619

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.