Summary
The FDA issued a Class II for Destino Twist 14F (also branded as Guidestar 14F) by Oscor Inc.. Reason: There is potential for separation between the threaded hub and threaded cap at the proximal end of the device..
Details
Source
Device Recall
External ID
Z-0646-2022
Action Date
2022-02-23
Status
Completed
Category
device
Product Description
Destino Twist 14F (also branded as Guidestar 14F)
Lot/Code Info: 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]
Quantity Affected: 549 units
Reason for Recall
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Distribution
Distribution to TN and PA in USA OUS distribution to Czech Republic
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-22
Company
Palm Harbor, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oscor Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oscor Inc. have FDA actions?
This is the only FDA action we have on record for Oscor Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0646-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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