Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

FDA Recall Z-1269-2020 · Posted 2020-01-27

Recalling FirmTELEFLEX MEDICAL INC
Recall StatusTerminated
Product CodeDWS
Date Initiated2020-01-13
Date Terminated2021-11-24
Product Quantity1764 units

Reason for Recall

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

Firm Action

The firm initiated the recall by letter on 01/13/2020. The actions to be taking be the consignees are as follows: Check inventory. If affected stock is found, discontinue use immediately and quarantine. Complete the acknowledgement form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. For additional questions, contact the local sales representative or Customer Service at 1-866-396-2111.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

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

↑