The Recall Desk
LowFDA (Devices)·Z-1998-2012·Announced 2012-07-18

PSC Industries Recalls Surgical Forceps Due to Labeling Errors

PSC Industries is recalling 40 units of Model #20-1360K surgical forceps because of typos in the inner packaging labels. The errors did not affect the part or lot numbers.

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 FDA Class II, but the source text explicitly states that the defect is a labeling error that did not affect the Part Number or Lot Number, and no injuries or illnesses are reported. This aligns with the rubric for cosmetic defects or documentation issues.

Plain-English summary

PSC Industries Inc is recalling 40 units of Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K. The recall involves Lot Number 023420 with an expiration date of 2/28/2017. The devices were distributed worldwide, including nationwide in the United States and in Canada and the Philippines.

The recall was initiated due to labeling errors on the inner Tyvek peel pouch. Specifically, the letter 'E' in the word 'Electrosurgical' was printed as an 'X', and the number '5' in the tip measurement was printed as a '0'. These errors affected the description and some text on the labels but did not alter the Part Number or Lot Number.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the labeling defects.

The recalled product

Product
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 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
Affected units
40

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: 20-1360K
  • Lot Number: 023420
  • Expiration Date: 2/28/2017.

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 →