Recall Z-1942-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olsen Medical
Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.
| Date | May 11, 2018 |
| Status | Terminated |
| Reason | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
| Root cause | Package design/selection |
| Action | Symmetry initiated their recall via Urgent Medical Device Recall notices on 05/11/2018 sending faxes to accounts, as applicable; and, will also send the Notice via US certified mail, with return receipt requested, and will also send the Notice via e-mail to those customers for which it has a valid e-mail address (as applicable). All customers were asked to quarantine any products that reflect a breach of the seal area or any products that they do not wish to inspect immediately and promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impa |
| Quantity | 323,886 devices |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111262 | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP Olsen Medical, May 23, 2012 |