Z-1584-2018Class II

5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840

Name: Z-1584-2018 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840
Creator: CooperSurgical, Inc.
Published: 2018-03-12
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2018-03-12 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are... on 2018-03-12. FDA classified it as Class II and gives the reason as "Products have been packaged with the wrong Trocar length type". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1584-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-05-01
Terminated: 2019-05-08
Recalling firm: CooperSurgical, Inc.
Product: 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.
Product code: DRC Trocar
Reason for recall: Products have been packaged with the wrong Trocar length type.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On March 26, 2018 CopperSurgical Inc. mailed a Medical Device Recall Notification to affected customers. Customers were instructed to discontinue the use of the affected lot number 223333 and complete an Acknowledgement and Receipt Form to schedule refund or exchanges. If customers supplied products to any other facility, they have been asked to provide the recipients a copy of the notification letter. Customers with questions may contact CopperSurgical at [email protected].
Quantity in commerce: 520 products
Distribution: Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
Product codes and lots: Lot number 223333

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1584-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1584-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01

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)