Bayonet Forceps 8.25 recall: Labeling Error
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…
Why was Bayonet Forceps 8.25 recalled?
Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/part Number: 20-11420, Lot Number: 023340, Expiration Date: 2/28/2017.
- 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…
- Recalling firm
- PSC Industries Inc
- Quantity
- 10 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
- Recall date
- July 18, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)