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FDA (Device enforcement)Recalled 2020-01-21closedclass ii

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

Is my product affected?

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

  • UPC 10193489219180

Check against the official notice below — it lists the full affected range.

What happened

Medline Industries Inc. has recalled Medline HOI Lumbar back support devices (Model DYNJ902823G, Lot 20AKA895, expiration date May 31, 2021) because the sterile pack inside the Complete Delivery System did not go through a complete sterilization cycle. This means the sterility of the components inside cannot be guaranteed. A total of 122 units were distributed to medical facilities in California, including Torrance Memorial Medical Center and Hoag Memorial Hospital.

The recall source does not specify what action affected consumers should take regarding this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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 Quantity: 122 Lot/code info: REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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