Recall Z-1945-2018— Olsen Medical

Name: FDA recall Z-1945-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-11

Class II · Terminated

Class II FDA medical device recall by Olsen Medical, initiated 2018-05-11, terminated 2019-04-15. It names one FDA 510(k) clearance: K080187. Product: 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: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised..

Recalling firm: Olsen Medical
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Terminated: 2019-04-15
Firm location: Louisville, KY, United States

510(k) clearances named in this recall

1 on FDA's record

K080187 — OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPSOlsen Medical·cleared 2008-05-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.