FDA recall Z-1944-2018

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

Reason for recall

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

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2018-05-11

Report date

2018-06-06

Termination date

2019-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1944-2018