PSC Industries Recalls Bayonet Forceps Due to Incorrect Expiration Date
PSC Industries is recalling 80 units of Bayonet Forceps because the outer carton lists an incorrect sterile expiration date, though the individual pouch labels are correct.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and packaging labeling issue where the correct expiration date is present on the individual device pouches, posing no direct risk of adverse health consequences.
Plain-English summary
PSC Industries Inc is recalling 80 units of Bayonet Forceps, Model #20-1360I, due to a labeling error on the outer carton. The outer carton label incorrectly lists the sterile expiration date as 2012-02-28, which is actually the manufacture date. The individual device pouch labels correctly list the sterile expiration date as 2017-02-28.
The affected devices are sterile, single-use surgical/bipolar forceps intended for coagulating tissue during surgical procedures. The recall involves Lot Number 023399. The devices were distributed worldwide, including nationwide in the United States and in Canada and the Philippines.
Consumers and healthcare facilities should stop using the recalled devices and contact PSC Industries Inc for further instructions. The error is limited to the outer carton labeling; the individual sterile pouches contain the correct expiration date.
The recalled product
- Product
- Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords…
- Manufacturer
- PSC Industries Inc
- Hazard
- Affected units
- 80
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 (3)
- Model/part Number: 20-1360I
- Lot Number: 023399
- Expiration Date: 02/28/2017.
Distribution
Part of a larger recall action
This product is one of 6 recalled by PSC Industries 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.
See all 6 products in this recall →Related recalls
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