Home Public Health Agencies US Food and Drug Administration Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath...

Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices

Reason for Announcement:

Recall Reason Description

Hub cap and seal on the proximal end of the device handle may detach during use

Company Name:
Oscor Inc.
Brand Name:
Product Description:

Product Description

Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath


Company Announcement

FOR IMMEDIATE RELEASE – January 11, 2022 – Palm Harbor, FL., Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the device handle detaching during use.

RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.
Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.

PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information on Tables 1, 2 and 3 below. The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.

TABLE 1: RECALLED PRODUCT IMPACTED

Product name UDI Number Model Lot Number Expiration Date Packaging State Type
Destino Twist 14F 00885672011123 DST1405525 PQOC13475 10-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 DP14073 11-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 DP14072 10-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 DP14071 10-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 DP13834 09-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 DP13828 09-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 DP13827 08-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 PQOC12995 07-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 PQOC12632 07-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 PQOC12633 07-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 PQOC12345 06-01-2024 Sterile
Guidestar 14F 00885692010911 D141103 PQOC12330 06-01-2024 Sterile

 

TABLE 2: DESTINO 14F TWIST MODEL

PRODUCT: Destino Twist 14F
GTIN (Unit) Model Sheath & Dilator French
Size
Quantity
00885672011123 DST1405525 S55CM D73CM 14F 6 Units

TABLE 3 GUIDESTAR 14F – MODEL

PRODUCT: Guidestar 14F
GTIN (Unit) Model Sheath & Dilator French
Size
Quantity
00885672010911 D141103 S71CM D89CM 14F 543 Units

 CUSTOMER MAY CONTACT:

Oscor Inc. is notifying its distributors and customers by email and is arranging for the return of all recalled products.

Customers with questions regarding this recall can contact Oscor’s Customer Relations Group, Monday to Friday from 8:30AM to 5:30PM Eastern Time at 727-937-2511 or via email at [email protected].

Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

END OF DOCUMENT


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