| Class 2 Device Recall bipolar cord | |
Date Initiated by Firm | May 11, 2018 |
Create Date | May 25, 2018 |
Recall Status1 |
Terminated 3 on April 15, 2019 |
Recall Number | Z-1942-2018 |
Recall Event ID |
80080 |
510(K)Number | K111262 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | 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' (3.6m), REF 40-1104, QTY 10
(f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10
(g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10
(h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10
(i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10
(j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10
(k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10
(l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10
(m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3003-R-39, QTY 10
(n) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF G-40-1102, QTY 10
Intended for use in coagulating tissue. |
Code Information |
all codes |
Recalling Firm/ Manufacturer |
Olsen Medical 3230 Commerce Center Pl Louisville KY 40211-1900
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For Additional Information Contact | 502-772-4272 |
Manufacturer Reason for Recall | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
FDA Determined Cause 2 | 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 impacted Products.
All customers outside of the United States (OUS) will be provided with the Notice via postal mail and through Symmetrys Distributors in each country and requested to quarantine immediately and promptly call Symmetry's Distributors to support the return of any products that have a breach of the seal area or which the customer does not wish to inspect.
Appropriate notifications will be sent to Health Authorities in Canada, European Union, and other countries that require notification of this recall. |
Quantity in Commerce | 323,886 devices |
Distribution | Worldwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GEI
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