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Recall Observatory FDA recall evidence

Device product

Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case

Z-1031-2023

November 17, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 91387
Status
Ongoing
Classification
Class II
Quantity
57 cases (114 units)
Official record key
device-enforcement:Z-1031-2023

Official wording

Reason: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Code information: Item Number: CDS980894A, UDI/GTIN Case: 40889942401292, UDI/GTIN Each: 10889942401291, Lot Numbers: 22HMD613, 22JMB665

Distribution pattern: US Nationwide distribution in the states of AR, MD, WA, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.