Recall Z-1945-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olsen Medical
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
| 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 | 4,110 devices |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080187 | OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS Olsen Medical, May 9, 2008 |