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Terminated

INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory

FDA Recall Z-2130-2017 · Posted None

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeGCD
Date Initiated2017-04-21
Date Terminated2020-01-27
Product Quantity19,043 units in total

Firm Action

Consignees were notified via Urgent Medical Device Recall letter on April 21, 2017. The letter identified the affected product, problem and actions to be taken. They were instructed to discontinue use and quarantine any products with the affected catalog numbers and lot numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax it to the Attn: Customer Service or email to [email protected]. A Recall Acknowledgment Form was enclosed to be completed and returned via fax even if they have no stock.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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