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U.S. Department of Health and Human Services

Class 2 Device Recall GRIPPER Needles

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  Class 2 Device Recall GRIPPER Needles see related information
Date Initiated by Firm July 08, 2019
Create Date October 24, 2019
Recall Status1 Terminated 3 on August 23, 2020
Recall Number Z-0190-2020
Recall Event ID 83286
510(K)Number K072657  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
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. 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;

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          
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
763-383-3072
Manufacturer Reason
for Recall		 Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
FDA Determined
Cause 2		 Process control
Action Smiths Medical notified customers during the week of 07/08/2019 via "URGENT MEDICAL DEVICE RECALL NOTICE" letter. The Recall Notice advised customers that Smiths Medical has initiated a voluntary field removal for specific lots of GRIPPER¿ needles and specific lots of PORT-A-CATH¿ Trays containing GRIPPER¿ needles. Customers were instructed to examine inventory for affected product and complete and return the Response Form to GRIPPERocclusion2019@smiths-medical.com. Once the response form is received, Customer Service will provide a shipping label to return all affected product to Stericycle. A copy of the completed Response Form must be included inside EACH BOX of returned product to facilitate processing. Ensure boxes are sealed and labeled with your facility name prior to shipping. Distributors were instructed to immediately notify customers if the product was further distributed. A copy of the Recall Notice and accompanying Response Form should be included. Questions regarding this notification can be sent to Smiths Medical via email at GRIPPERocclusion2019@smiths-medical.com.
Quantity in Commerce 3,952,509 devices total
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = SMITHS MEDICAL MD, INC.
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