# FDA recall Z-0190-2020

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2019-07-08.

## Product

GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM.  Labeled as the following item descriptions:      1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO     1/EA;      2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO     1/EA;      3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO     1/EA;      4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO     1/EA;      5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO     1/EA;      6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO     1/EA;      7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED     1/EA;      8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED     1/EA;      9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO     1/EA;      10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO     1/EA;      11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO     1/EA;      12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU     1/EA;      13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU     1/EA;      14

## Reason for recall

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

## Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR.      International distribution

## Key facts

- **Recall number:** Z-0190-2020
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-08
- **Report date:** 2019-10-30
- **Termination date:** 2020-08-23

- **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-0190-2020

## Citation

> AI Analytics. FDA recall Z-0190-2020. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0190-2020. Source: US FDA. Licensed CC0.

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