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U.S. Department of Health and Human Services

Class 2 Device Recall Destino Twist

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  Class 2 Device Recall Destino Twist see related information
Date Initiated by Firm December 22, 2021
Create Date February 17, 2022
Recall Status1 Completed
Recall Number Z-0646-2022
Recall Event ID 89392
510(K)Number K140406  
Product Classification Introducer, catheter - Product Code DYB
Product Destino Twist 14F (also branded as Guidestar 14F)
Code Information 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] 
Recalling Firm/
Manufacturer		 Oscor Inc.
3816 Desoto Blvd
Palm Harbor FL 34683-1618
For Additional Information Contact Bethania Tavarez
727-937-2511 Ext. 110
Manufacturer Reason
for Recall		 There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 549 units
Distribution Distribution to TN and PA in USA OUS distribution to Czech Republic
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Oscor Inc.
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