Z-1994-2012 Class II Terminated
FDA device recall Z-1994-2012 was initiated by PSC Industries Inc on June 1, 2012 and is designated Class II. Reason for recall: Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging. The recall status is terminated (terminated September 15, 2015). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2012
- Initiation Date
- June 1, 2012
- Termination Date
- September 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
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 in coagulating tissue during surgical procedures.
Reason for Recall
Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
Code Information
Model/part Number: 90-7004, Lot Numbers: 017897