# FDA recall Z-1358-2020

> **Medline Industries Inc** · Class II · device recall initiated 2020-01-21.

## Product

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

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

## Key facts

- **Recall number:** Z-1358-2020
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-21
- **Report date:** 2020-03-04
- **Termination date:** 2023-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2020

## Citation

> AI Analytics. FDA recall Z-1358-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1358-2020. Source: US FDA. Licensed CC0.

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