FDA Device recall Z-0646-2022
Destino Twist 14F (also branded as Guidestar 14F)
- FDA Device
- Class II
- completed
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of Destino Twist 14F (also branded as Guidestar 14F) by Oscor, citing there is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0646-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-12-22 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Oscor |
| Distribution | PA, TN |
Product
Destino Twist 14F (also branded as Guidestar 14F)
Reason
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Identifiers
| code_info | 1) Model DST1405525 (Destino Twist 14F) - a) Lot: PQOC13475 [UDI: (01)00885672011123(11)211014(17)241001(10)PQOC134…1) Model DST1405525 (Destino Twist 14F) - a) Lot: PQOC13475 [UDI: (01)00885672011123(11)211014(17)241001(10)PQOC13475] 2) Model D141103 (Guidestar 14F) - Lots: a) DP14073 - [UDI: (01)00885672010911(11)211114(17)241101(10)DP14073] b) DP14072 - [UDI: (01)00885672010911(11)211024(17)241001(10)DP14072] c) DP14071 - [UDI: (01)00885672010911(11)211023(17)241001(10)DP14701] d) DP13834 - [UDI: (01)00885672010911(11)210919(17)240901(10)DP13834] e) DP13828 - [UDI: (01)00885672010911(11)210914(17)240901(10)DP13828] f) DP13827 - [UDI: (01)00885672010911(11)210826(17)240801(10)DP13827] g) DP13811 - [UDI: (01)00885672010911(11)210812(17)240801(10)DP13811] h) DP13812 - [UDI: (01)00885672010911(11)210812(17)240801(10)DP13812] i) PQOC12995 - [UDI: (01)00885672010911(11)210709(17)240701(10)PQOC12995] j) PQOC12632 - [UDI: (01)00885672010911(11)210706(17)240701(10)PQOC12632] k) PQOC12633 - [UDI: (01)00885672010911(11)210705(17)240701(10)PQOC12633] l) PQOC12345 - [UDI: (01)008856 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0646-2022%22
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