CLASS II Device recall · Reported 23 Feb 2022 · FDA Enforcement Report
Destino Twist 14F (also branded as Guidestar 14F) recalled by Oscor
Oscor is recalling Destino Twist 14F (also branded as Guidestar 14F), distributed in Pennsylvania, Tennessee. The recall was initiated on 22 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0646-2022
- FDA event ID
- 89392
- Recalling firm
- Oscor, Palm Harbor, FL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 22 Dec 2021
- FDA classified
- 17 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2021 | Recall initiated by company | |
| 17 Feb 2022 | Classified by FDA | +57 days |
| 23 Feb 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Product as listed by the FDA
Destino Twist 14F (also branded as Guidestar 14F)
Where it was distributed
Distribution to TN and PA in USA OUS distribution to Czech Republic
Questions about this recall
Why was it recalled?
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Which lots are affected?
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)00885672010911(11)210622(17)240601(10)PQOC12345] m) PQOC12330 - [UDI: (01)00885672010911(11)210602(17)240601(10)PQOC12330]
Where was it sold?
Distribution to TN and PA in USA OUS distribution to Czech Republic
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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