Recall Z-1374-2021— Arrow International Inc

Name: FDA recall Z-1374-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-08

Class II · Ongoing

Class II FDA medical device recall by Arrow International Inc, initiated 2021-03-08. It names one FDA 510(k) clearance: K113872. Product: Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.. Reason: Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-03-08
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K113872 — THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACAREVidacare Corporation·cleared 2012-03-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.

Reason for recall

Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure

Data sourced from openFDA. This site is unofficial and independent of the FDA.