# FDA recall Z-1073-2018

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2017-12-04.

## Product

PORT-A-CATH  II PS/Titan, Tray PAC II.  Labeled as:      a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA);    b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA);    c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)

## Reason for recall

Certain models and lots of PORT A CATH implantable  port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.

## Distribution

Worldwide Distribution.  US nationwide including Puerto Rico,  Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.

## Key facts

- **Recall number:** Z-1073-2018
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-04
- **Report date:** 2018-03-21
- **Termination date:** 2020-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1073-2018

## Citation

> AI Analytics. FDA recall Z-1073-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1073-2018. Source: US FDA. Licensed CC0.

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