Integra York Metzenbaum Scissors Recalled Due to Packaging Seal Separation
Integra York PA, Inc. is recalling 50 units of sterile Metzenbaum Scissors 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 the compromise of sterility poses a potential infection risk, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Integra York PA, Inc. is recalling 50 units of Metzenbaum Scissors 7", Curved, Sterile. These single-use sterile surgical instruments are intended for cutting and grasping tissue in general surgical procedures. The recall is due to a defect in the packaging where the Chevron seals of the 6x10 Tyvek peel pouch may separate, causing the packages to open and compromising the sterility of the instruments.
The affected products are identified by Catalog # ST5-182 and lot # 355. The recall covers units distributed in North Carolina and Texas. No specific dates of distribution are provided in the source text.
Healthcare facilities and consumers should stop using the affected instruments and contact the recalling firm for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- 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.
- Manufacturer
- Integra York PA, Inc
- Affected units
- 50
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 # ST5-182
- lot# 355
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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