FDA Device recall Z-2424-2015
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disp…
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disp… by International Biophysics, citing it was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2424-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-07 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | International Biophysics |
| Distribution | US |
Product
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
Reason
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Identifiers
| code_info | 031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 05…031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541 |
|---|
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-2424-2015%22
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