Z-0190-2020Class II

GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item...

Name: Z-0190-2020 GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item...
Creator: Smiths Medical ASD Inc.
Published: 2019-07-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-07-08 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2019-07-08. FDA classified it as Class II and gives the reason as "Potential for certain GRIPPER Needles to contain an occluded or blocked needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0190-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Posted: 2019-10-24
Terminated: 2020-08-23
Recalling firm: Abbott Medical
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;
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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 [email protected].
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0190-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23
Z-0190-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23

Product code LJT

K072657Class IIPower Port-a-Cath, Cath II, and P.a.s. Port T2 Power P.a.c. Implantable Venous Access Systems and Power Gripper PlusSmiths Medical MD, Inc. / cleared 2007-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)