FDA Device

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

Hazard

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

What You Should Do

Remedy

Oscor issued customer letters to impacted consignees on January 7 and 11, 2022. Distributors are asked to immediately check inventory for affected product and quarantine any recalled devices. All downstream customers (hospitals/end users) should be identified and this recall should be communicated to those customers immediately. All retrieved inventory is to be returned to Oscor. An acknowledgement form must be completed and returned to Oscor via fax (727-934-9835) or via email to recall@Oscor.com.

Products

Destino Twist 14F (also branded as Guidestar 14F)
Brand
Oscor Inc.
UPC
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]

Units Affected

549 units