Z-0147-2015Class II

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

Name: Z-0147-2015 Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy
Creator: CooperSurgical, Inc. D.B.A. Lone Star Medical Products
Published: 2013-09-13
License: https://open.fda.gov/license/

Lone Star Medical Products / initiated 2013-09-13 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. D.B.A. Lone Star Medical Products began a recall of Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy on 2013-09-13. FDA classified it as Class II and gives the reason as "CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0147-2015
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Posted: 2014-10-29
Terminated: 2015-09-23
Recalling firm: Lone Star Medical Products
Product: Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
Product code: DRC Trocar
Reason for recall: CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 90 units
Distribution: Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
Product codes and lots: Lots 149460 and 149911

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0147-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0147-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-29

Product code DRC

K911462Class IISurgical TrocarApplied Medical / cleared 1991-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)