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Recall Observatory FDA recall evidence

Device product

Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL

Z-1070-2023

November 17, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 91386
Status
Ongoing
Classification
Class II
Quantity
174 cases (750 units)
Official record key
device-enforcement:Z-1070-2023

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. ORAL SURGERY PACK-LF, Item Number: DYNJ20491N, Case UDI/GTIN: 40195327024582, Unit UDI/GTIN: 10195327024581, Lot Number: 22IDA002; b. EXTRACTION PACK, Item Number: DYNJ49329F, Case UDI/GTIN: 40195327059638, Unit UDI/GTIN: 10195327059637, Lot Number: 22HBR730; c. ORAL SURGERY PACK, Item Number: DYNJ52404G, Case UDI/GTIN: 40195327222612, Unit UDI/GTIN: 10195327222611, Lot Number: 22IDA539,22HDB737; d. DENTAL MINOR PACK, Item Number: DYNJ83140, Case UDI/GTIN: 40195327232956, Unit UDI/GTIN: 10195327232955, Lot Number: 22JBN386; e. ORAL, Item Number: DYNJ902377G, Case UDI/GTIN: 40195327224746, Unit UDI/GTIN: 10195327224745, Lot Number: 22KBG529,22JBO834;

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.

Field note

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