Integra York Recalls Sterile Rochester-Pean Hemostatic Forceps Due to Seal Defect
Integra York PA, Inc. is recalling 150 units of sterile Rochester-Pean Hemostatic Forceps because packaging seals may separate, compromising sterility.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile surgical instruments) where a defect compromises sterility, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Integra York PA, Inc. is recalling 150 units of Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. These single-use sterile surgical instruments are intended for cutting and grasping tissue in general surgical procedures. The affected units are identified by Catalog # ST7-138 and lot # 352.
The recall was initiated because the Chevron seals of the 6x10 Tyvek peel pouches used to package the instruments may separate. This defect can cause the packages to open, which compromises the sterility of the instruments. The products were distributed in North Carolina and Texas.
Healthcare facilities and consumers should stop using these specific instruments and contact the recalling firm for further instructions or replacement.
The recalled product
- 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.
- Manufacturer
- Integra York PA, Inc
- Affected units
- 150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog # ST7-138
- lot# 352
Distribution
Part of a larger recall action
This product is one of 2 recalled by Integra York PA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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