Reported Jun 24, 2026 · Ongoing
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN…
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?
53 of 53 products
| # | Product as published |
|---|---|
| 1 | Description/REF: ACCESS TRAY/GU-04020 |
| 2 | PSI KIT: 8.5 FR/AK-09803-CDC |
| 3 | PSI KIT: 9 FR/AK-09903-CDC |
| 4 | PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1 |
| 5 | PSI KIT: 9 FR X 10 CM/ASK-09903-KH |
| 6 | PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1 |
| 7 | PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA |
| 8 | PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH |
| 9 | PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL |
| 10 | PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC |
| 11 | PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC |
| 12 | PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4 |
| 13 | PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3 |
| 14 | MULTI-LUMEN/PSI KIT/AK-11142-SPCS |
| 15 | MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A |
| 16 | MULTI-LUMEN/PSI KIT/AK-11142-D |
| 17 | MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4 |
| 18 | MULTI-LUMEN/PSI KIT/NA-11242-CDC |
| 19 | MULTI-LUMEN/PSI KIT/AK-21142-SK |
| 20 | MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG |
- Lot codes and dates
53 of 53 products
Products covered by this recall # Barcodes Product as published 1 30801902118807108019021932753080190211880730801902118807GU-04020/30801902118807, 10801902193275, 30801902118807, 30801902118807/33F24C0753, 33F24E0736, 33F24G0154, 33F24G0648, 33F24H0377, 33F25A0059, 33F25A0072, 33F25A0395, 33F25F0260, 33F25G0736, 33F25H0298, 33F25J0603, 33F26B0084, 33F26B0314, 33F26C0578, 33F24D0036 2 208019021217561080190219327510801902117417AK-09803-CDC/20801902121756, 10801902193275, 10801902117417/33F24B0126, 33F24B0127, 33F24C0021, 33F24D0021, 33F24E0072, 33F24G0338, 33F24G0587, 33F24J0506, 33F24K0105, 33F24L0722, 33F25A0468, 33F25C0107, 33F25C0953, 33F25E0054, 33F25E0921, 33F25G0086, 33F25H0023, 33F25J0828, 33F25K0255, 33F25K0364, 33F25L0328, 33F24A0239 3 108019021174171080190219327520801902121916AK-09903-CDC/10801902117417, 10801902193275, 20801902121916/33F24A0356, 33F24B0128, 33F24B0129,33F24C0022, 33F24D0022, 33F24E0074, 33F24E0075, 33F24G0340, 33F24G0588, 33F24J0507, 33F24K0107, 33F24L0676, 33F24L0759, 33F25A0470, 33F25C0108, 33F25C0730, 33F25E0056, 33F25E0923, 33F25H0025, 33F25J0471, 33F25K0031, 33F25L0237, 33F25M0920, 33F26A1053, 33F24A0386 4 10801902193275ASK-09810-PCMH1/10801902193275/33F25K0051, 33F24J0109 5 1080190211935010801902193275ASK-09903-KH/10801902119350, 10801902193275/33F24D0713, 33F24K0385, 33F24L1060, 33F25D0340, 33F25E0778, 33F25H0567, 33F25M0163, 33F26A1407, 33F25E1184 6 1080190219327510801902115222ASK-09903-PHP1/10801902193275, 10801902115222/33F24J0115, 33F25H0497, 33F26A0410, 33F24F0625 7 1080190219327510801902118193ASK-09903-UPA/10801902193275, 10801902118193/33F24K0387, 33F24L0855, 33F24A0787 8 108019021181931080190219327510801902118209ASK-09903-YNH/10801902118193, 10801902193275, 10801902118209/33F24E0527, 33F24H0478, 33F24L0682, 33F25H0135, 33F25J0915, 33F24A0110 9 1080190211820910801902193275ASK-09907-SL/10801902118209, 10801902193275/33F24D0053, 33F24D0967, 33F24G0265, 33F25E0215, 33F25E0454, 33F25G0680, 33F25J0551, 33F25K0328, 33F25L0206, 33F26C0312, 33F25B0188 10 108019021199301080190219327510801902119947NA-09803-CDC/10801902119930, 10801902193275, 10801902119947/33F24C0756, 33F24E0739, 33F25A0342, 33F25J0615, 33F26B0028, 33F24A1327 11 108019021199471080190219327510801902119954NA-09903-CDC/10801902119947, 10801902193275, 10801902119954/33F24E0740, 33F24H0381, 33F24J0199, 33F24J0361, 33F24L0020, 33F25B0278, 33F25C0551, 33F25E0340, 33F25E0400, 33F25E0468, 33F25F0419, 33F25H0708, 33F26A1655, 33F26B0023, 33F24A0113 12 1080190219327510801902224344ASK-09903-ECL4/10801902193275, 10801902224344/33F26A1582, 33F26B0399, 33F25E0534 13 108019021932751080190218984110801902212006ASK-09903-MGH3/10801902193275, 10801902189841, 10801902212006/33F25C0264, 33F25G0338, 33F25J0360, 33F25K0130, 33F26B0126, 33F26C0004, 33F24D0780 14 108019021964121080190219327560801902123093AK-11142-SPCS/10801902196412, 10801902193275, 60801902123093/33F24A0382, 33F24A1019, 33F24C0024, 33F24E0078, 33F24E0154, 33F24G0343, 33F24J0510, 33F24K0110, 33F24L0673, 33F25A0472, 33F25C0381, 33F25C0389, 33F25C0952, 33F25E0059, 33F25H0027, 33F25J0831, 33F25K0302, 33F25L0365, 33F26B0514, 33S24J0510, 33F24D0075 15 608019021167361080190219327540801902111768CDC-11242-1A/60801902116736, 10801902193275, 40801902111768/33F24D0431, 33F24E0213, 33F24F0140, 33F24F0220, 33F24G0103, 33F24H0392, 33F24H0425, 33F24H0450, 33F24L0011, 33F25B0018, 33F25B0096, 33F25D0705, 33F25E1120, 33F25F0024, 33F25F0414, 33F25G0043, 33F25G0486, 33F25J0016, 33F25J0992, 33F25K0308, 33F25M0481, 33F24C1001 16 208019021219161080190219327510801902196412AK-11142-D/20801902121916, 10801902193275, 10801902196412/33F24A1018, 33F24C0023,33F24E0077, 33F24G0342,33F24J0509, 33F24K0109, 33F24L0615, 33F25A0471, 33F25C0842, 33F25E0058, 33F25G0088, 33F25J0472, 33F25K0301, 33F25L0467, 33F26B0593, 33F26B0958, 33F24A0252 17 108019021932751080190218986510801902182545ASK-11142-MGH4/10801902193275, 10801902189865, 10801902182545/33F25D0466, 33F25F0113, 33F25L0130, 33F25M0398, 33F26A1539, 33F26B0680, 33F24D0736 18 108019021199541080190219327510801902119978NA-11242-CDC/10801902119954, 10801902193275, 10801902119978/33F24A0817, 33F24A1218, 33F24B0399, 33F24C0270, 33F24G0554, 33F24J0663, 33F24L0743, 33F25C0197, 33F25C0870, 33F25E0273, 33F25H0179, 33F25H0761, 33F25L0419, 33F26B0562, 33F24C0271 19 108019021932753080190212224830801902122255AK-21142-SK/10801902193275, 30801902122248, 30801902122255/33F24G0356, 33F24G0589, 33F24J0520, 33F24K0122, 33F24L0670, 33F25A0480, 33F25C0720, 33F25E0071, 33F25H0030, 33F25J0837, 33F25L0473, 33F25M0964, 33F26A1097, 33F26B0956, 33R24L0670, 33F24D0023 20 10801902193275ASK-21142-LMDTG/10801902193275/33F25K0417, 33F25F0007 - Amount recalled
- 426,041
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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