FDAFDA · Food and drugs·Recall number Z-1358-2020
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Published March 4, 2020 · Recall initiated: January 21, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medline Industries Inc
- Distributor
- 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
- Lot
- REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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