FDA Enforcement
Class II
Terminated
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
Recall: Z-1995-2012
·
Reported July 18, 2012
Enforcement
- Recall Number
- Z-1995-2012
- Event ID
- 61958
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- PSC Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 18, 2012
- Initiation Date
- June 1, 2012
- Classification Date
- July 11, 2012
- Termination Date
- September 15, 2015
- Address
- 3230 Commerce Center Pl, Louisville, KY, 40211-1900, United States
Description
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
Reason
Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm).
Code Info
Model/part Number: 41604, Lot Number: 019737, and 021578.
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.
Quantity
5 units