Z-0190-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- July 8, 2019
- Termination Date
- August 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,952,509 devices total
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;
Reason for Recall
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
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
Code Information
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