Reported Jun 24, 2026 · Ongoing
Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4;…
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?
59 of 59 products
| # | Product as published |
|---|---|
| 1 | Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH |
| 2 | PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4 |
| 3 | PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1 |
| 4 | PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1 |
| 5 | PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4 |
| 6 | PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1 |
| 7 | PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A |
| 8 | PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3 |
| 9 | MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2 |
| 10 | MULTI LUMEN/PSI KIT/ASK-11142-NSU |
| 11 | MULTI-LUMEN/PSI KIT/AK-21242-X |
| 12 | MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC |
| 13 | MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1 |
| 14 | MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5 |
| 15 | MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT |
| 16 | 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1 |
| 17 | 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2 |
| 18 | MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1 |
| 19 | MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH |
| 20 | MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1 |
- Lot codes and dates
59 of 59 products
Products covered by this recall # Barcodes Product as published 1 108019021932751080190213936510801902143874ASK-09701-UMH/10801902193275, 10801902139365, 10801902143874/33F24M0171, 33F25A0444, 33F25G0008, 33F25K0039, 33F25L0133, 33F26B0369, 33F23K0811 2 1080190221207510801902193275ASK-09803-OSU4/10801902212075, 10801902193275/33F24F0994, 33F24K0428, 33F25B0183, 33F25D0761 3 10801902193271080190216183010801902136678ASK-09903-AMC1/1080190219327, 10801902161830, 10801902136678/33F25A0437, 33F25E0024, 33F25G0690, 33F25L0142, 33F26C0117, 33F24B0612 4 1080190213667810801902193275ASK-09903-CMC1/10801902136678, 10801902193275/33F24D0050, 33F24D0965, 33F24F0130, 33F24J0321, 33F24J0627, 33F24L0585, 33F25A0110, 33F25C0176, 33F25C0588, 33F25E0212, 33F25E1020, 33F25F0324, 33F25G0753, 33F25L0208, 33F26A0396, 33F26A1255, 33F25E0716 5 1080190221200610801902193275ASK-09903-OSU4/10801902212006, 10801902193275/33F24G0022, 33F24L0298, 33F25D0762 6 1080190219327520801902115205ASK-09903-PCMH1/10801902193275, 20801902115205/33F25L0139, 33F26B0136, 33F24H0108 7 508019021167151080190219327560801902116729CDC-09803-1A/50801902116715, 10801902193275, 60801902116729/33F24D0892, 33F24F0766, 33F24L0274, 33F25B0147, 33F25C0497, 33F25C0498, 33F25D0553, 33F25E0647, 33F25F0209, 33F25H0574, 33F25L0121, 33F25M0410, 33F24D0504 8 10801902193275ASK-09903-ECL3/10801902193275/33F25G0241, 33F25H0530, 33F25J0357, 33F26A0015 9 1080190219327510801902196436ASK-11242-PHP2/10801902193275, 10801902196436/33F24J0117, 33F24K0727, 33F25A0009, 33F25E0003, 33F25F0359, 33F25K0040, 33F25L0132, 33F26B0223, 33F26D0016, 33F24K0544 10 1080190218254510801902193275ASK-11142-NSU/10801902182545, 10801902193275/33F24E0326, 33F24K0354, 33F24L0244, 33F24L0300, 33F25B0189, 33F25C0228, 33F25D0467, 33F25E0591, 33F25G0272, 33F25G0405, 33F25H0629, 33F25J0363, 33F26A1572, 33F26B0816, 33F24L0840 11 108019021932753080190212226280801902123127AK-21242-X/10801902193275, 30801902122262, 80801902123127/33F24G0358, 33F24J0522, 33F24K0124, 33F24L0749, 33F25B0683, 33F25E0073, 33F25J0479, 33F25L0443, 33F26C0301, 33F24D0371 12 108019021932751080190221893010801902206685ASK-21142-DMC/10801902193275, 10801902218930, 10801902206685/33F25B0242, 33F25M0671, 33F26A0237, 33F26B0946, 33F24D0718 13 1080190219327510801902200492ASK-21142-GMC1/10801902193275, 10801902200492/33F25B0642, 33F25E0719, 33F25H0582, 33F25M0147, 33F26C0335, 33F24F0098 14 108019022004921080190219327510801902200492ASK-21142-HF5/10801902200492, 10801902193275, 10801902200492/33F24F0921, 33F24K0350, 33F24L0245, 33F25A0168, 33F25C0272, 33F25D0344, 33F25F0103, 33F25G0282, 33F25H0614, 33F25J0371, 33F26A1525, 33F26C0040, 33F24L0309 15 1080190219327510801902220728ASK-21142-LMDT/10801902193275, 10801902220728/33F25A0041, 33F25B0381, 33F25D0346, 33F25F0172, 33F25K0416, 33F25M0343, 33F26B0189, 33F26C0139, 33F25K0206 16 10801902193275ASK-21142-UCL1/10801902193275/33F25E0541, 33F25G0391, 33F25J0102, 33F25J0373, 33F25M0235, 33F26A1375, 33F24H0098 17 108019021594791080190219327510801902225365ASK-21142-UPMC2/10801902159479, 10801902193275, 10801902225365/33F24F0879, 33F24J0161, 33F24L0310, 33F24L1023, 33F25C0276, 33F25E0780, 33F25G0348, 33F25J0209, 33F26A1371, 33F26A1547, 33R25G0348, 33F26C0490 18 10801902193275ASK-21242-SL1/10801902193275/33F26A1347, 33F25E0314 19 108019021295021080190219327510801902156348ASK-21242-UMH/10801902129502, 10801902193275, 10801902156348/33F24E0637, 33F24F0895, 33F24L0317, 33F25B0197, 33F25C0280, 33F25D0478, 33F25F0178, 33F25H0564, 33F25L0106, 33F26A1517, 33F24F0618 20 1080190219327510801902156348ASK-21242-UN1/10801902193275, 10801902156348/33F24H0146, 33F25A0438, 33F25D0032, 33F25E0315, 33F25F0236, 33F25H0778, 33F25K0044, 33F26A0252, 33F26B0219, 33F26C0048, 33F25C0816 - Amount recalled
- 348,684
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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