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Stryker Pneumosure Insufflator Tubing
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| Nonconforming Material/Component | |||||||||||||||||||||||||||
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| Urgent Medical Device Recall letters were sent to domestic customers on March 28, 2016 by certified mail. Stryker International distribution sites were notified and are responsible for providing information to affected customers. | |||||||||||||||||||||||||||
| 489 | |||||||||||||||||||||||||||
| Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala. | |||||||||||||||||||||||||||
| TPLC Device Report | |||||||||||||||||||||||||||
| 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. | |||||||||||||||||||||||||||
| 510(K) Database | 510(K)s with Product Code = HIF and Original Applicant = W.O.M. WORLD OF MEDICINE AG | ||||||||||||||||||||||||||