Food, drugs, devices › Integra York PA, Inc
Device recall: Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-us
FDA enforcement event 75710 is a device recall by Integra York PA, Inc of York, PA, initiated 28 Oct 2016 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 17 Apr 2017. Initiation: voluntary: firm initiated. Integra York PA, Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra York PA, Inc, York, PA.
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."
Distribution
"US Distribution in NC and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0751-2017 | 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. | 150 units | Class II | Terminated | 21 Dec 2016 |
| Z-0752-2017 | Metzenbaum Scissors 7 , Curved, Sterile The Metzenbaum Scissors 7 , Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures. | 50 units | Class II | Terminated | 21 Dec 2016 |
Context
Other enforcement events for Integra York PA, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Mar 2016 | Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument. | Device | Class II | 1 |
| 30 Jul 2014 | Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, | Device | Class II | 1 |
All 3 events for Integra York PA, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution in NC and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.