PSC Industries Recalls Bipolar Bayonet Forceps Due to Packaging Labeling Error
PSC Industries is recalling 7 units of Bipolar Bayonet Forceps because the manufacturer symbol was incorrectly replaced by the expiry symbol on the packaging.
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 for a packaging labeling error (misbranding) with no reported injuries or illnesses, fitting the criteria for cosmetic defects or documentation issues.
Plain-English summary
PSC Industries Inc is recalling 7 units of Bipolar Bayonet Forceps 7.75" (Model #90-7004, Lot #017897). The recall was initiated because the devices are misbranded; specifically, the manufacturer symbol on the packaging was replaced by the expiry symbol.
The affected devices are reusable, non-sterile electrosurgical/bipolar forceps intended for use in coagulating tissue during surgical procedures. The 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 stop using the affected forceps and contact PSC Industries Inc for further instructions.
The recalled product
- Product
- Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use…
- Manufacturer
- PSC Industries Inc
- Hazard
- Affected units
- 7
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 (2)
- Model/part Number: 90-7004
- Lot Numbers: 017897
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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