Vistec recallZ-0534-2018 · Covidien LP · initiated Jul 17, 2017
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 Covidien LP 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
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
FDA root cause category: Material/Component Contamination
What the company is doing
Medtronic sent an Urgent Medical Device Recall letter dated July 17, 2017 to their customers via Federal Express or certified mail. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine, discontinue use and return affected product. Customers were instructed to acknowledge receipt of the Urgent Field Corrective Action Notice. For questions contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Recall details
- Recall number
- Z-0534-2018
- Status
- Terminated
- Initiated by the company
- Jul 17, 2017
- Recalling firm
- Covidien LP
- Quantity
- 33,280
- Product code
- GDY
- Distribution
- U.S., Gov Accts, and foreign countries: PA, PR, CO.
Product description
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
Code information (models, lots, serial numbers)
Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vistec 7317Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 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.
How recalls are matched to devices · Editorial policy · Report an error on this page