Reported Apr 18, 2018 · Terminated
AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3)…
Arrow International 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: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
42 of 42 products
| Model / number | Product as published |
|---|---|
AK-42703-P1A | AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) |
| — | (2) AK-45703-P1A |
| — | (3) AK-45703-PB1A |
| — | AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A |
| — | (5) CA-42854-P1A |
| — | (6) CA-45703-P1A |
| — | AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-45854-P1A |
| — | (8) CDA-42703-P1A |
| — | AGB+ Quad-Lumen CVC Kit (9) AK-42854-P1A |
| — | (10) AK-45854-P1A |
| — | AGB+ Two Lumen CVC Kit (11) AK-42802-P1A |
| — | (12) AK-45802-P1A |
| — | (13) AK-46702-P1A |
| — | (14) AK-47702-P1A |
| — | ARROWg+ard BLUE PLUS Pressure Injectable Multi-Lumen CVC Kit (15) CDA-45703-P1A |
| — | ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit (16) CDA-45854-P1A |
| — | ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit (17) CDA-22122-U1A |
| — | (18) CDA-42802-P1A |
| — | (19) CDA-42854-P1A |
| — | (20) CDA-47702-P1A |
- Lot codes and dates
42 of 42 products
Products covered by this recall # Product as published 1 (1) 13F17A0135, 13F17C0355, 13F17E0212, 13F17E0789, 13F17F0386 2 (2) 13F17A0028, 13F17E0044, 13F17E0448 3 (3) 13F17B0118, 13F17F0385 4 (4) 13F17B0152, 13F17C0057 5 (5) 13F17F0226 6 (6) 13F17A0157, 13F17B0117, 13F17C0250 7 (7) 13F17F0071 8 (8) 13F17A0022, 13F17A0301, 13F17C0266, 13F17D0039 9 (9) 13F17B0041, 13F17E0764 10 (10) 13F16M0169, 13F17B0262, 13F17C0468 11 (11) 13F17D0323, 13F17E0310, 13F17E0467 12 (12) 13F17B0085, 13F17E0150, 13F17F0345 13 (13) 13F17E0751 14 (14) 13F17E0211 15 (15) 13F17A0167, 13F17B0145, 13F17C0466, 13F17E0095, 13F17F0261 16 (16) 13F17C0325, 13F17D0283 17 (17) 13F17E0616, 13F17F0256 18 (18) 13F17C0318 19 (19) 13F16M0048, 13F17E0124,13F17F0497 20 (20) 13F17B0249
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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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