In accordance with Article 34, Paragraph 1 of the Medical Device Act, we announce the suspension of sale, recall, and recall order.
1. Collection obligor (contact information): Inseong Medical Co., Ltd. (033-812-3800)
2. Medical device subject to recall: Tube catheter for oxygen administration (Reception number 08-1860)
3. Risk level: 3
4. Recall lot (manufacturing date): 2180397('18.06.22), 2182209('19.01.29), 2190211('19.04.09), 2190850('19.07.12) 2191154('19.08.02), 2191217('19.08.02), 2191224('19.08.02)
5. Reason for recall: Obtaining risk information - There is a risk that the port of the swivel elbow will crack and leak from the crack, and it may affect the patient's respiratory function and vital signs. Overseas cases have been reported showing that it may have harmful effects. - Voluntary recall by importer expanded from overseas to domestic, resulting in recall order from the Ministry of Food and Drug Safety
6. Collection method: Direct collection and repair by dealers (distributors) and salespeople
8. Collection period: August 12, 2019 ~ November 12, 2019
9. Announcement date: December 31, 2019
Sellers and medical institutions that store the medical devices subject to recall are requested to immediately stop selling and using them and contact us to request a recall.
In accordance with Article 34, Paragraph 1 of the Medical Device Act, we announce the suspension of sale, recall, and recall order.
1. Collection obligor (contact information): Inseong Medical Co., Ltd. (033-812-3800)
2. Medical device subject to recall: Tube catheter for oxygen administration (Reception number 08-1860)
3. Risk level: 3
4. Recall lot (manufacturing date): 2180397('18.06.22), 2182209('19.01.29), 2190211('19.04.09), 2190850('19.07.12) 2191154('19.08.02), 2191217('19.08.02), 2191224('19.08.02)
5. Reason for recall: Obtaining risk information - There is a risk that the port of the swivel elbow will crack and leak from the crack, and it may affect the patient's respiratory function and vital signs. Overseas cases have been reported showing that it may have harmful effects. - Voluntary recall by importer expanded from overseas to domestic, resulting in recall order from the Ministry of Food and Drug Safety
6. Collection method: Direct collection and repair by dealers (distributors) and salespeople
8. Collection period: August 12, 2019 ~ November 12, 2019
9. Announcement date: December 31, 2019
Sellers and medical institutions that store the medical devices subject to recall are requested to immediately stop selling and using them and contact us to request a recall.