Reported Jun 24, 2026 · Ongoing
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5…
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?
23 of 23 products
| # | Product as published |
|---|---|
| 1 | Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP |
| 2 | PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5 |
| 3 | PSI KIT: 8.5 FR/ASK-09807-UC |
| 4 | PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2 |
| 5 | PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG |
| 6 | PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5 |
| 7 | PSI KIT: 9 FR X 10 CM/CDC-09903-1A |
| 8 | MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2 |
| 9 | MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1 |
| 10 | MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4 |
| 11 | MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1 |
| 12 | 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT |
| 13 | PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH |
| 14 | PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2 |
| 15 | PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1 |
| 16 | PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC |
| 17 | PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT |
| 18 | PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM |
| 19 | PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1 |
| 20 | PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 1080190214387410801902193275ASK-09701-UP/10801902143874, 10801902193275/33F23K0811, 33F24B0340, 33F24E0524, 33F24G0489, 33F25C0874, 33F25E1018, 33F25H0747, 33F25J0795, 33F26A0402, 33F26B0243, 33F26B1031 2 10801902193275ASK-09803-OSU5/10801902193275/33F25D0761, 33F25E0533, 33F25M0683 3 1080190214584710801902193275ASK-09807-UC/10801902145847, 10801902193275/33F24B0018, 33F24F0004, 33F24J0478, 33F25C0175, 33F25E0210, 33F25E1208, 33F25G0676, 33F25L0211 4 10801902193275ASK-09903-HH2/10801902193275/33F25E0534, 33F25G0167, 33F25H0565, 33F25J0358, 33F25M0234, 33F26C0332 5 10801902193275ASK-09903-LMDTG/10801902193275/33F25E1184, 33F25F0112, 33F25H0375 6 10801902193275ASK-09903-OSU5/10801902193275/33F25D0762 7 6080190211672910801902193275CDC-09903-1A/60801902116729, 10801902193275/33F24D0504, 33F24F0227, 33F24H0267, 33F24H0434, 33F24J0219, 33F24K0023, 33F24M0015, 33F24M0109, 33F25B0006, 33F25B0067, 33F25C0417, 33F25D0696, 33F25D0718, 33F25E1148, 33F25F0023, 33F25G0445, 33F25G0513, 33F25G0605, 33F25G0668, 33F26A1644 8 1080190219327510801902222500ASK-11242-KSF2/10801902193275, 10801902222500/33F25D0231, 33F25D0468, 33F25E0592, 33F25K0131, 33F26A1360, 33F26B0425 9 10801902193275ASK-11242-KSF1/10801902193275/33F24L0840, 33F25B0190 10 1080190219327510801902222746ASK-21142-NWM/10801902193275, 10801902222746/33F25F0007, 33F25F0173, 33F25J0207, 33F25M0008, 33F26A1438, 33F26B0197 11 1080190219327510801902221022ASK-21242-MCY1/10801902193275, 10801902221022/33F24H0123, 33F25C0342, 33F25E0671, 33F25K0138, 33F26B0441 12 1080190219327510801902222562ASK-21242-OSU4/10801902193275, 10801902222562/33F25D0757, 33F25E0672, 33F25H0445, 33F25H0651, 33F25L0230, 33F26B0795 13 1080190219327510801902221633ASK-21242-UCD1/10801902193275, 10801902221633/33F25E0314, 33F25M0681, 33F26B0138 14 1080190219327510801902211450ASK-21142-HHC/10801902193275, 10801902211450/33F24L0309, 33F25C0273, 33F25G0170, 33F25H0440, 33F25J0372, 33F26B0125 15 1080190219327510801902220698ASK-21242-LMDT/10801902193275, 10801902220698/33F25C0696, 33F25E0544, 33F26A1526, 33F26B0464 16 1080190214102310801902193275ASK-09804-CCH/10801902141023, 10801902193275/33F24D0899, 33F24F0836, 33F24L0295, 33F25B0184, 33F25C0261, 33F25E0777, 33F25G0410, 33F25J0356, 33F26A1369, 33F26C0041 17 1080190219327510801902221930ASK-29803-MM2/10801902193275, 10801902221930/33F25E0549, 33F26A1352, 33F26B0176, 33F26C0031 18 10801902193275ASK-29903-DU1/10801902193275/33F24H0139, 33F25A0171, 33F25E0553, 33F25H0426, 33F25M0012 19 10801902193275ASK-29903-HHC/10801902193275/33F25D0235, 33F25L0263, 33F26A1431 20 10801902193275ASK-29903-LMDT/10801902193275/33F25D0480, 33F25K0208, 33F25K0420 - Amount recalled
- 72,354
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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