Home / Recalls / Olsen Medical / Z-1945-2018

Z-1945-2018 Class II Terminated

Recalled by Olsen Medical — Louisville, KY

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
May 11, 2018
Termination Date
April 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,110 devices

Product Description

Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10

Reason for Recall

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Distribution Pattern

Worldwide Distribution

Code Information

all codes

Other recalls by Olsen Medical

  • Z-1942-2018 Class II — Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded I (May 11, 2018)
  • Z-1941-2018 Class II — Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Elect (May 11, 2018)
  • Z-1943-2018 Class II — Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Conn (May 11, 2018)
  • Z-1944-2018 Class II — Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25 (May 11, 2018)