Product Safety Recalls

Product Recall Tracker

Oscor Inc. Recall 89392

Description: Destino Twist 14F (also branded as Guidestar 14F)

Oscor Inc. Recall 89392 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0646-2022
Event ID89392
Event DescriptionDestino Twist 14F (also branded as Guidestar 14F)
Product TypeDevices
DistributionDistribution to TN and PA in USA OUS distribution to Czech Republic
Quantity549 units
Recall ReasonThere is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Device Classification20220223
Device Code Info1) 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]
Center Classification Date20220217
Recall Initiation Date20211222
Recalling FirmOscor Inc.
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.