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Recall Observatory FDA recall evidence

Device product

Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

Z-1357-2020

January 21, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 84908
Status
Terminated
Classification
Class II
Quantity
122
Official record key
device-enforcement:Z-1357-2020

Official wording

Reason: The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

Code information: REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

Distribution pattern: California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.