FDA Device recall Z-1999-2012
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937 by Psc Industries, citing 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"….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1999-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-01 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Psc Industries |
| Distribution | US |
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. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
Reason
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.
Identifiers
| code_info | Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1999-2012%22
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