SafeSheath Ultra Lite recallZ-1329-2021 · Oscor, Inc. · initiated Mar 10, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oscor, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for open seal on sterile product
FDA root cause category: Under Investigation by firm
What the company is doing
The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product.
Recall details
- Recall number
- Z-1329-2021
- Status
- Terminated
- Initiated by the company
- Mar 10, 2021
- Recalling firm
- Oscor, Inc.
- Quantity
- 500 devices
- Product code
- DYB
- Distribution
- US Nationwide distribution in the state of New York.
Product description
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Code information (models, lots, serial numbers)
GUDID: 25051684026298; Lot Number DP-11759
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SafeSheath® Ultra Lite VI10Oscor Inc. · INTRODUCER, CATHETER1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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