| Date Initiated by Firm | December 22, 2021 |
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| Create Date | February 17, 2022 |
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| Recall Status1 |
Completed |
| Recall Number | Z-0646-2022 |
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| Recall Event ID |
89392 |
| 510(K)Number | K140406 |
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| 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] |
| FEI Number |
1035166
|
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. |
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FDA Determined
Cause 2 | Process control |
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| 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 |
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| 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
|
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