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

Bronchial Double Lumen Tube Set (Right), Sterile

FDA Recall Z-2408-2015 · Posted 2015-08-18

Recalling FirmTeleflex, Inc.
Recall StatusTerminated
Product CodeBTS
Date Initiated2014-11-21
Date Terminated2017-08-15

Reason for Recall

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Firm Action

Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts.

Root Cause

Other

Distribution Pattern

AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951091RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl. · 1995-06-08

Official Source

View FDA Recall →

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

↑