SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER 의 안전성 경고

Safety alert

2018-09-14

2018-09-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180914.html

Medical device safety alert: coopersurgical single-use cpo-6 colpo-pneumo occluder medical device manufacturer, coopersurgical, has issued a medical device safety alert concerning its single-use cpo-6 colpo-pneumo occluder [part number: cpo-6; lot numbers: 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 247609, 247610, & 248112] the manufacturer is recalling 26 lots of the affected product due to the possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. this condition was detected during a complaint investigation unrelated to the packaging seal. there have not been any adverse events reported to coopersurgical due to this potential issue. the manufacturer has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches. according to the manufacturer, a product is acceptable for use if it is visually confirmed that the pouch’s seal is intact. as indicated in the directions for use, each package should be handled with care and inspected for damage, including the seal area before use. the affected users are advised to inspect the package contents and the sterile seal along the entire periphery of the package. they should discontinue use of the product with any packaging irregularities and quarantine the product, product replacement is on-going. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 september 2018.