Z-1358-2020 Class II Terminated
FDA device recall Z-1358-2020 was initiated by Medline Industries Inc on January 21, 2020 and is designated Class II. 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. The recall status is terminated (terminated January 12, 2023). Affected quantity: 122.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- January 21, 2020
- Termination Date
- January 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122
Product Description
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
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 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
Code Information
REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350