[Recalled] Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar |
|---|---|
| Brand / manufacturer | PSC Industries Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1996-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 June 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from PSC Industries Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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