The Recall Desk
LowFDA (Devices)·Z-1996-2012·Announced 2012-07-18

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.

What this means for you

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 - Ol
Manufacturer
PSC Industries Inc
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

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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 →