Z-0751-2017Class II

Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved...

Name: Z-0751-2017 Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved...
Creator: Integra York PA, Inc
Published: 2016-10-28
License: https://open.fda.gov/license/

Miltex, Inc. / initiated 2016-10-28 / Terminated / root cause: manufacturing process

FDA source

Integra York PA, Inc began a recall of Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended... on 2016-10-28. FDA classified it as Class II and gives the reason as "The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0751-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-28
Posted: 2016-12-13
Terminated: 2017-04-17
Recalling firm: Miltex, Inc.
Product: Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Product code: GEN Forceps, General & Plastic Surgery
Reason for recall: The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Integra, mailed an "URGENT MEDICAL DEVICE RECALL NOTICE" dated October 26, 2016 to customers affected by the recall to notify them of the issue. The notice described the product, problem and actions to be taken. The customers were instructed to immediately review their inventory to determine if they had any of the recalled product on hand and to discontinue distributing the product; review your customer traceability records for shipment of the product and forward a copy of this Recall Notice to any of your customers that purchased the affected lots; complete and return the Acknowledgement Form that accompanied the notice (even if you do not have any product(s)) by email to: [email protected] or fax to: 1-609-750-4220. Should you have any questions regarding these instructions, please contact Customer Service at 1-866-854-8300.
Quantity in commerce: 150 units
Distribution: US Distribution in NC and TX.
Product codes and lots: Catalog # ST7-138; lot# 352

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0751-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0751-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-13
Z-0752-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-13

Product code GEN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)