Recall Z-0751-2017— Integra York PA, Inc
Class II · Terminated
Class II FDA medical device recall by Integra York PA, Inc, initiated 2016-10-28, terminated 2017-04-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Integra York PA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-28
- Terminated
- 2017-04-17
- Firm location
- York, PA, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.