Recall Z-0147-2015— CooperSurgical, Inc. D.B.A. Lone Star Medical Products

Name: FDA recall Z-0147-2015
Creator: U.S. Food and Drug Administration
Published: 2013-09-13

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc. D.B.A. Lone Star Medical Products, initiated 2013-09-13, terminated 2015-09-23. It names one FDA 510(k) clearance: K911462. Product: Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.. Reason: CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper..

Recalling firm: CooperSurgical, Inc. D.B.A. Lone Star Medical Products
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Terminated: 2015-09-23
Firm location: Stafford, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K911462 — SURGICAL TROCARApplied Medical·cleared 1991-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.