Recall Z-1944-2018— Olsen Medical
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: K130669. Product: Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.0mm Tips, REF 20-0321, QTY 5 (d1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.5mm Tips, REF 20-0331, QTY 5 (e1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth, 1.5mm Tips, REF 20-0331R, QTY 5 (f1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth Micro Tips, REF 20-0351, QTY 5 (g1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361, QTY 5 (h1) Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 0.5mm Tips, REF 20-0361G, QTY 5 (i1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361R, QTY 5 (j1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371, QTY 5 (k1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371R, QTY 5 (l1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381, QTY 5 (m1)Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 1.5mm Tips, REF 20-0381G, QTY 5 (n1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381R, QTY 5 (o1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411, QTY 5 (p1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411R, QTY 5 (q1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421, QTY 5 (r1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421R, QTY 5 (s1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431, QTY 5 (t1) Insulated Irrigating Bayonet Forceps 8.25" (309.6mm) 1.5mm Tips, REF 20-0431G, QTY 5 (u1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431R, QTY 5 (v1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481, QTY 5 (w1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481R, QTY 5 (x1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491, QTY 5 (y1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491R (z1) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 0.5mm Tips, REF 20-0571IMT, QTY 5 (a2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.0mm Tips, REF 20-0572IMT, QTY 5 (b2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.5mm Tips, REF 20-0573IMT, QTY 5 (c2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 0.5mm Tips, REF 20-0581IMT, QTY 5 (d2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.0mm Tips, REF 20-0582IMT, QTY 5 (e2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.5mm Tips, REF 20-0583IMT, QTY 5 (f2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 0.5mm Tips, REF 20-0591IMT, QTY 5 (g2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.0mm Tips, REF 20-0592IMT, QTY 5 (h2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.5mm Tips, REF 20-0593IMT (i2) Insulated Coaptation Forceps 4.5" (11.4cm) Smooth Micro Tips, Angled, REF 20-1010KI, QTY 10 (j2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, REF 20-1030K, QTY 10 (k2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040K, QTY 10 (l2) Insulated Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040KI, QTY 10 (m2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K, QTY 10 (n2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K-28, QTY 10 (o2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060KI, QTY 10 (p2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Ti. 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 recordK-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 bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.0mm Tips, REF 20-0321, QTY 5 (d1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.5mm Tips, REF 20-0331, QTY 5 (e1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth, 1.5mm Tips, REF 20-0331R, QTY 5 (f1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth Micro Tips, REF 20-0351, QTY 5 (g1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361, QTY 5 (h1) Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 0.5mm Tips, REF 20-0361G, QTY 5 (i1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361R, QTY 5 (j1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371, QTY 5 (k1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371R, QTY 5 (l1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381, QTY 5 (m1)Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 1.5mm Tips, REF 20-0381G, QTY 5 (n1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381R, QTY 5 (o1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411, QTY 5 (p1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411R, QTY 5 (q1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421, QTY 5 (r1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421R, QTY 5 (s1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431, QTY 5 (t1) Insulated Irrigating Bayonet Forceps 8.25" (309.6mm) 1.5mm Tips, REF 20-0431G, QTY 5 (u1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431R, QTY 5 (v1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481, QTY 5 (w1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481R, QTY 5 (x1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491, QTY 5 (y1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491R (z1) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 0.5mm Tips, REF 20-0571IMT, QTY 5 (a2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.0mm Tips, REF 20-0572IMT, QTY 5 (b2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.5mm Tips, REF 20-0573IMT, QTY 5 (c2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 0.5mm Tips, REF 20-0581IMT, QTY 5 (d2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.0mm Tips, REF 20-0582IMT, QTY 5 (e2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.5mm Tips, REF 20-0583IMT, QTY 5 (f2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 0.5mm Tips, REF 20-0591IMT, QTY 5 (g2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.0mm Tips, REF 20-0592IMT, QTY 5 (h2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.5mm Tips, REF 20-0593IMT (i2) Insulated Coaptation Forceps 4.5" (11.4cm) Smooth Micro Tips, Angled, REF 20-1010KI, QTY 10 (j2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, REF 20-1030K, QTY 10 (k2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040K, QTY 10 (l2) Insulated Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040KI, QTY 10 (m2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K, QTY 10 (n2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K-28, QTY 10 (o2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060KI, QTY 10 (p2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Ti
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.