The Recall Desk
ModerateFDA (Devices)·Z-1999-2012·Announced 2012-07-18

PSC Industries Recalls Irrigating Bayonet Forceps Due to Labeling Errors

PSC Industries is recalling 125 units of Irrigating Bayonet Forceps because of typographical errors on the inner packaging labels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is a labeling error that did not affect the Part or Lot numbers, fitting the rubric for minor labeling errors.

Plain-English summary

PSC Industries Inc is recalling 125 units of Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Model #20-0431. The recall involves a specific lot (023340) with an expiration date of 02/28/2017. The devices are sterile surgical instruments intended for electro-surgery for coagulation and irrigation of tissue.

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 affected units were distributed worldwide, including nationwide in the United States (specifically CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX) and in Canada and the Philippines. Consumers and healthcare facilities should check their inventory for this specific model and lot number and stop using the devices if they match the recalled description.

The recalled product

Product
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayone
Manufacturer
PSC Industries Inc
Affected units
125

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: 20-0431I
  • Lot Number: 023340
  • 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 →