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

Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.

FDA Recall Z-0147-2015 · Posted 2014-10-29

Recalling FirmCooperSurgical, Inc. D.B.A. Lone Star Medical Products
Recall StatusTerminated
Product CodeDRC
Date Initiated2013-09-13
Date Terminated2015-09-23
Product Quantity90 units

Reason for Recall

CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.

Firm Action

CooperSurgical sent an Urgent Field Safety Notice ( Correction ) dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm provided correct package inserts (IFU) to affected consignees. The recalling firm intends to conduct effectiveness checks by reviewing return receipts from the initial recall communication. We apologize for any inconvenience this communication may cause. If you have any questions or concerns, please contact CooperSurgical at (203) 601-9818.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911462SURGICAL TROCARApplied Medical · 1991-04-22

Official Source

View FDA Recall →

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

↑