Oscor Inc.: Destino Twist 14F (also branded as Guidestar 14F)

Is my product affected?

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

• UPC 00885672011123
• UPC 00885672010911

Check against the official notice below — it lists the full affected range.

What happened

Oscor Inc. is recalling the Destino Twist 14F and Guidestar 14F devices due to a potential separation between the threaded hub and threaded cap at the proximal end of the device. A total of 549 units were distributed to Tennessee and Pennsylvania in the United States, as well as to the Czech Republic. The affected devices include Model DST1405525 (Destino Twist 14F) and Model D141103 (Guidestar 14F) across multiple lot numbers.

The specific lot numbers affected are: for the Destino Twist 14F, lot PQOC13475; and for the Guidestar 14F, lots DP14073, DP14072, DP14071, DP13834, DP13828, DP13827, DP13811, DP13812, PQOC12995, PQOC12632, PQOC12633, PQOC12345, and PQOC12330. Consumers can identify affected devices using the unique device identifiers (UDIs) listed for each lot. The recall record does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Details from the source

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 Quantity: 549 units 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]

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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