FDA Enforcement
Class II
Terminated
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.
Recall: Z-0751-2017
·
Reported December 21, 2016
Enforcement
- Recall Number
- Z-0751-2017
- Event ID
- 75710
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra York PA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 21, 2016
- Initiation Date
- October 28, 2016
- Classification Date
- December 13, 2016
- Termination Date
- April 17, 2017
- Address
- 589 Davies Dr, York, PA, 17402-8630, United States
Description
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.
Reason
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.
Code Info
Catalog # ST7-138; lot# 352
Distribution
US Distribution in NC and TX.
Quantity
150 units