FDA Device recall Z-0137-2014
Surgicutt fully automated incision making device for bleeding time determination
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Surgicutt fully automated incision making device for bleeding time determination by Itc Nexus Dx, citing ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0137-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-22 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Itc Nexus Dx |
| Distribution | US |
Product
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.
Reason
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Identifiers
| code_info | Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017 |
|---|
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-0137-2014%22
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