Reported Jun 24, 2026 · Ongoing
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A;…
Arrow International, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: ARROW INTERNATIONAL, LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
80 of 80 products
| # | Product as published |
|---|---|
| 1 | Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A |
| 2 | AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A |
| 3 | AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A |
| 4 | AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM |
| 5 | AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK |
| 6 | AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB |
| 7 | AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC |
| 8 | AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK |
| 9 | AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB |
| 10 | AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC |
| 11 | PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK |
| 12 | PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB |
| 13 | PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC |
| 14 | PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB |
| 15 | PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB |
| 16 | PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB |
| 17 | PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC |
| 18 | PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB |
| 19 | PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC |
| 20 | PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB |
- Lot codes and dates
93 of 93 products
Products covered by this recall Model / number Barcodes Product as published — 10801902193275CDC-02031-MK1A/10801902193275/33F25C0444 — 10801902193275CDC-41541-MPK1A/10801902193275/33F24L1137 — 1080190219327550801902130162CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571 — 1080190219327510801902218862ASK-41541-VFHM/10801902193275, 10801902218862/33F24L1080, 33F25B0475, 33F25C0351, 33F25D0404, 33F25E0556, 33F25E0784, 33F25F0186, 33F25J0218, 33F25K0077, 33F25K0100, 33F25M0182, 33F26A1549, 33F26B0823 — 1080190219327510801902193275CDC-41541-MPK/10801902193275, 10801902193275/33F25H0768, 33S23K0382 — 1080190219327510801902205411CDC-41541-MPKB/10801902193275, 10801902205411/33F24H0429, 33F24K0043, 33F24M0067, 33F24M0149, 33F25A0390, 33F25B0099, 33F25B0343, 33F25C0578, 33F25E0421, 33F25F0401, 33F25G0515, 33F25G0710, 33F25H0817, 33F25J1008, 33F25L0015, 33F25L0050, 33F25L0295, 33F25M0499, 33F26A0330, 33X25J0003 — 1080190220543510801902193275CDC-41541-MPKC/10801902205435, 10801902193275/33F24D0982, 33F24F0166, 33F24F0167, 33F24H0398, 33F24H0454, 33F24J0380, 33F24J0389, 33F24K0581, 33F24L0182, 33F24M0022, 33F24M0077, 33F25A0348, 33F25B0228, 33F25B0281, 33F25B0289, 33F25B0344, 33F25C0513, 33F25C0532, 33F25C0558, 33F25D0710, 33F25D0736, 33F25F0020, 33F25F0025, 33F25F0032, 33F25H0818, 33F25J0577, 33F25J0657, 33F25L0251, 33F25L0296, 33S25A0211, 33F26C0435 — 10801902201505CDC-41552-MPK/10801902201505/33F24D0561, 33F26B0490, 33S24A0521 — 1080190219327510801902205428CDC-41552-MPKB/10801902193275, 10801902205428/33F24J0183, 33F24J0221, 33F24L0010, 33F24L0173, 33F24M0114, 33F25B0223, 33F25B0299, 33F25D0724, 33F25F0436, 33F25G0640, 33F25K0354, 33F25L0265, 33F26B1048 — 1080190220544210801902193275CDC-41552-MPKC/10801902205442, 10801902193275/33F24C0861, 33F24D0343, 33F24F0090, 33F24K0474, 33F25C0208, 33F25D0559, 33F25E0827, 33F25H0608, 33F25J0434, 33F25M0248, 33F26A1559, 33F26C0776 — 1080190219327510801902201475CDC-32041-MPK/10801902193275, 10801902201475/33F25C0701, 33F25H0613, 33F25J0433, 33F25L0115, 33F25M0250, 33F26B0436 — 1080190220539810801902193275CDC-32041-MPKB/10801902205398, 10801902193275/33F24D0854, 33F24F0897, 33F24L0952, 33F25B0502, 33F25D0512, 33F25E0825, 33F25G0327, 33F25J0327, 33F25M0210, 33F26B0434, 33S23E0870 — 10801902193275CDC-32041-MPKC/10801902193275/33F25D0513, 33F25H0590, 33F26A1387 — 1080190220540410801902193275CDC-32052-MPKB/10801902205404, 10801902193275/33F24F0825, 33F24L0381, 33F25D0514, 33F25H0609 — 1080190219327510801902208757DLX-35541-CURVB/10801902193275, 10801902208757/33F25D0674, 33F25J0186, 33S23G0883, 33S23H0988 — 10801902193275DLX-35541-HPKB/10801902193275/33F25D0129, 33F25E0708 — 10801902193275DLX-35541-HPKC/10801902193275/33F25D0244, 33F25E0830 — 10801902193275DLX-35552-HPKB/10801902193275/33F25D0246, 33F25D0518, 33F25F0149 — 1080190219327510801902216721DLX-35552-HPKC/10801902193275, 10801902216721/33F25D0247, 33F25D0519, 33F25H0460, 33S23K0380 — 10801902193275DLX-35563-HPKB/10801902193275/33F25K0318 - Amount recalled
- 177,014
This recall covers 35 products
The agency filed one notice per product. You are reading one of them; the other 34 are below.
22 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Using this product could cause serious injury, illness or death — stop using it now.
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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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