Smiths Medical ASD Inc. 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; Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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;
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Smiths Medical ASD Inc. is recalling GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item d due to Potential for certain GRIPPER Needles to contain an occluded or blocked needle.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026