Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1997-2012·Announced 2012-07-18

PSC Industries Recalls Surgical Forceps Due to Labeling Errors

PSC Industries is recalling Bayonet Forceps due to typos in the inner packaging labels. The errors did not affect the part or lot numbers.

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 2/5 (Moderate).

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 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

PSC Industries Inc is recalling Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420. The recall involves 10 units of the device, which are packaged one per Tyvek peel pouch with ten pouches per box.

The recall was initiated because of 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 change the Part Number or Lot Number.

The affected devices 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. The specific lot number is 023340, with an expiration date of 2/28/2017. Consumers and healthcare providers should check their inventory for this specific model and lot number and stop using the affected devices.

The recalled product

Product: Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar…
Manufacturer: PSC Industries Inc
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling
Affected units: 10

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: 20-11420
Lot Number: 023340
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 →

Same manufacturer · PSC Industries Inc

See all →

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Same hazard · mis labeling