{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "6000 Nathan Ln N",
      "reason_for_recall": "Potential for certain GRIPPER Needles to contain an occluded or blocked needle.",
      "address_2": "",
      "product_quantity": "3,952,509 devices total",
      "code_info": "1. Item Number 21-4025-24, Lot Numbers 3674105, 3694006, 3712500, 3736641, 3748406, 3756975;      2. Item Number 21-4037-24, Lot Numbers 3659767, 3674101, 3690401, 3694005, 3703706, 3709205, 3731036, 3765362;      3. Item Number 21-4051-24, Lot Number: 3624979;      4. Item Number 21-4053-24, Lot Number 3659766, 3662933, 3731032;      5. Item Number 21-4055-24, Lot Numbers: 3683539, 3690396, 3690397, 3703705, 3709204, 3712498, 3717709, 3736577, 3748401, 3756973, 3765356, 3765357, 3765358, 3765360;      6. Item Number 21-4065-24, Lot Number: 3668869;      7. Item Number 21-4068-24, Lot Number: 3749691;      8. Item Number 21-4069-24, Lot Number: 3765354;      9. Item Number 21-4071-24, Lot Numbers: 3618196, 3740043;      10. Item Number 21-4073-24, Lot Numbers: 3687796, 3690395, 3731024, 3736575;      11. Item Number 21-4083-24, Lot Numbers: 3662930, 3662931, 3662932, 3756971, 3765346, 3765348;      12. Item Number 21-4153-24, Lot Numbers: 3628064, 3674098;      13. Item Number 21-4155-24, Lot Numbers: 3659764, 3674097, 3687795, 3717706, 3736572, 3776589;      14. Item Number 21-4171-24, Lot Numbers: 3696520, 3709202, 3772784;      15. Item Number 21-4183-24, Lot Numbers: 3731023, 3736569, 3756970;      16. Item Number 21-4187-24, Lot Numbers: 3756969, 3772751;      17. Item Number 21-4423-24, Lot Numbers: 3659762, 3662929, 3666142, 3756968, 3765344;      18. Item Number 21-4425-24, Lot Numbers: 3696519, 3717705, 3736566;      19. Item Number 21-4437-24, Lot Numbers: 3655263, 3666141, 3683517, 3694001, 3724970, 3730962, 3748385, 3748386, 3756965;      20. Item Number 21-4453-24, Lot Numbers: 3659761, 3662927, 3712497, 3730960, 3736565, 3748382, 3749695, 3765338;      21. Item Number 21-4455-24, Lot Numbers: 3643998, 3662926, 3666139, 3671489, 3674096, 3687793, 3690392, 3696517, 3703702, 3706172, 3712495, 3730957, 3736563, 3740039, 3748380, 3756963, 3772703;      22. Item Number 21-4465-24, Lot Numbers: 3655261, 3693997, 3736554;      23. Item Number 21-4471-24, Lot Numbers: 3703701, 3717695, 3717696, 3730951, 3730952, 3756958;      24. Item Number 21-4474-24, Lot Numbers: 3666137, 3765332;      25. Item Number 21-4475-24, Lot Numbers: 3655257, 3666126, 3709201, 3717694, 3736553, 3740036, 3756957, 3765329, 3765330;      26. Item Number 21-4476-24, Lot Numbers: 3655256, 3659759;      27. Item Number 21-4477-24, Lot Numbers: 3655255, 3674095, 3687791, 3690388, 3703700, 3706171, 3709200, 3719958, 3730948, 3740035, 3748373, 3756954;      28. Item Number 21-4483-24, Lot Numbers: 3655254, 3669980, 3679144, 3690385, 3690386, 3696515, 3703678, 3706170, 3730946, 3736551, 3740034, 3749697, 3756952;      29. Item Number 21-4485-24, Lot Numbers: 3679481, 3683507;      30. Item Number 21-4873-24, Lot Numbers: 3655242, 3659737, 3693996, 3706169, 3730945, 3748364, 3756946;      31. Item Number 21-8066-24, Lot Number: 3756945;      32. Item Number 21-8466-24, Lot Numbers: 3662921 ,3730943, 3756938;      33. Item Number 21-8468-24, Lot Numbers: 3659735, 3666104, 3765319;      34. Item Number 21-8470-24, Lot Numbers: 3655234, 3666103, 3696513, 3730942",
      "center_classification_date": "20191023",
      "distribution_pattern": "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",
      "state": "MN",
      "product_description": "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. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU     1/EA;      15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU     1/EA;      16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL     1/EA;      17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO     1/EA;      18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO     1/EA;      19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO     1/EA;      20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO     1/EA;      21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO     1/EA;      22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO     1/EA;      23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO     1/EA;      24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED     1/EA;      25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED     1/EA;      26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED     1/EA;      27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED     1/EA;      28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO     1/EA;      29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO     1/EA;      30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO     1/EA;      31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO     1/EA;      32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO     1/EA;      33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO     1/EA;      34.  TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED     1/EA;",
      "report_date": "20191030",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Smiths Medical ASD Inc.",
      "recall_number": "Z-0190-2020",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "83286",
      "termination_date": "20200823",
      "more_code_info": "",
      "recall_initiation_date": "20190708",
      "postal_code": "55442-1690",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}