Reported Oct 30, 2019 · Terminated
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1.…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
34 of 34 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
34 of 34 products
Products covered by this recall Model / number Product as published 21-4025-24Lot Numbers 3674105, 3694006, 3712500, 3736641, 3748406, 3756975 21-4037-24Lot Numbers 3659767, 3674101, 3690401, 3694005, 3703706, 3709205, 3731036, 3765362 21-4051-24Lot Number: 3624979 21-4053-24Lot Number 3659766, 3662933, 3731032 21-4055-24Lot Numbers: 3683539, 3690396, 3690397, 3703705, 3709204, 3712498, 3717709, 3736577, 3748401, 3756973, 3765356, 3765357, 3765358, 3765360 21-4065-24Lot Number: 3668869 21-4068-24Lot Number: 3749691 21-4069-24Lot Number: 3765354 21-4071-24Lot Numbers: 3618196, 3740043 21-4073-24Lot Numbers: 3687796, 3690395, 3731024, 3736575 21-4083-24Lot Numbers: 3662930, 3662931, 3662932, 3756971, 3765346, 3765348 21-4153-24Lot Numbers: 3628064, 3674098 21-4155-24Lot Numbers: 3659764, 3674097, 3687795, 3717706, 3736572, 3776589 21-4171-24Lot Numbers: 3696520, 3709202, 3772784 21-4183-24Lot Numbers: 3731023, 3736569, 3756970 21-4187-24Lot Numbers: 3756969, 3772751 21-4423-24Lot Numbers: 3659762, 3662929, 3666142, 3756968, 3765344 21-4425-24Lot Numbers: 3696519, 3717705, 3736566 21-4437-24Lot Numbers: 3655263, 3666141, 3683517, 3694001, 3724970, 3730962, 3748385, 3748386, 3756965 21-4453-24Lot Numbers: 3659761, 3662927, 3712497, 3730960, 3736565, 3748382, 3749695, 3765338 - Amount recalled
- 3,952,509 devices total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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