FDA Device recall Z-1064-2016
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath… by Arrow International, citing arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a poten….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1064-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-12 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr. Rx only. The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
Reason
Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.
Identifiers
| code_info | Material number :CL-07035 Batch #'s: CF0045142 CF0087118 CF0090127 CF0128575 CF1022799 CF1034863 CF1046302 CF10…Material number :CL-07035 Batch #'s: CF0045142 CF0087118 CF0090127 CF0128575 CF1022799 CF1034863 CF1046302 CF1060275 CF1083652 CF2019968 CF2021329 CF2045237 CF2056298 CF2092322 CF2125658 CF3031070 14F13G0157 14F13H0140 14F13K0108 14F13K0334 14F14A0435 14F14B0295 14F14C0449 14F14F0184 14F14F0282 14F14J0055 14F14L0126 14F15A0097 14F15A0473 14F15C0455 14F15C0455 14F15E0083 14F15E0392 14F15G0350 14F15L0009 Material #: CL-07635 Batch #'s: CF0014629 CF0016145 CF0026765 CF0027875 CF0029004 CF0031879 CF0043747 CF0044445 CF0045312 CF0046072 CF0057307 CF0058371 CF0058639 CF0059715 CF0060443 CF0061539 CF0062000 CF0062968 CF0074416 CF0074954 CF0086388 CF0088268 CF0098848 CF0099814 CF0090135 CF0090990 CF0104732 CF0115512 CF0115640 CF0117991 CF0128581 CF0129532 CF1022803 CF1022900 CF1023194 CF1035539 CF1046005 CF1046603 CF1057461 CF1058601 CF1069026 CF1069417 CF1071115 CF1071530 CF1082816 CF1083655 CF1084050 CF1094 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1064-2016%22
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