FDA Device recall Z-1830-2012
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen cathet…
- FDA Device
- Class I
- terminated
- Published 2012-07-04
On 2012-07-04 the FDA classified a Class I recall of Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen cathet… by Arrow International, citing lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1830-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-05-03 |
| Published | 2012-07-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
Reason
Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
Identifiers
| code_info | Part numbers (PN) AD-24703 -- lots ZF0088927, ZF0099619, ZF0099893, ZF0100764, ZF0111386, ZF0112205, ZF1013500, ZF10245…Part numbers (PN) AD-24703 -- lots ZF0088927, ZF0099619, ZF0099893, ZF0100764, ZF0111386, ZF0112205, ZF1013500, ZF1024535, ZF1025078, ZF1036034, ZF1036293, ZF1047553, ZF1068055, ZF1079398, ZF1080286, ZF1091018, ZF1102643, ZF1103235, ZF1113530, ZF1114129, ZF1114632, and ZF2016475. PN AD-24703-OB -- lots ZF1013508, ZF1024536, ZF1025079, ZF1036035, ZF1036449, ZF1057072, ZF1068314, ZF1079528, ZF1080288, ZF1080633, ZF1091019, ZF1092076, ZF1102574, ZF1124769, ZF1124963, ZF1125081, and ZF2016671. PN AD-24730-E -- lots ZF0111748, ZF0122465, ZF1013943, ZF1024429, ZF1035851, ZF1035852, ZF1046809, ZF1047095, ZF1056833, ZF1068324, ZF1068691, ZF1080036, ZF1080307, ZF1091021, ZF1102236, ZF1102876, ZF1113491, ZF1113853, ZF1114656, and ZF1125078. PN AD-24730-OB -- lots ZF0111749, ZF1013521, ZF1024545, ZF1035853, ZF1047096, ZF1056829, ZF1080032, ZF1091022, ZF1125298, ZF1125525, and ZF2016325. PN AD-24730-OL -- lots ZF1013523, ZF1024547, ZF1035855, ZF1056827, ZF1068325, ZF1068941, ZF1080034, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1830-2012%22
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