Reported Jun 6, 2018 · Terminated
Symmetry Olsen bipolar cord
Olsen Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olsen Medical · 3230 Commerce Center Pl · Louisville, KY · 40211-1900
Is this the product you have?
Symmetry Olsen bipolar cord
14 of 14 products
| Model / number | Product as published |
|---|---|
87500 | QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m) |
40-1102 | QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m) |
40-1102SPC | QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m) |
40-1103 | QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m) |
40-1104 | QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector |
40-1105-28 | QTY 10 (g) Bipolar Cord, 39 mm Fixed Pin Connector |
40-1105-39 | QTY 10 (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o |
40-1106-28 | QTY 10 (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m) |
40-1113 | QTY 10 (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m) |
40-1114 | QTY 10 (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m) |
40-1115-28 | QTY 10 (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m) |
40-3001R | QTY 10 (m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m) |
40-3003-R-39 | QTY 10 (n) Bipolar Cord, Twin Pin Connector, 12' (3.6m) |
G-40-1102 | QTY 10 Intended for use in coagulating tissue. |
- Lot codes and dates
- all codes
- Amount recalled
- 323,886 devices
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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