U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Tray, catheterization, sterile urethral, with or without catheter (kit) - Product Code FCM
원인
The firm has determined that there is a possibility that packaging seals may be compromised. the issue could result in an injury to the patient due to product contamination or loss of sterility condition.
조치
Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions:
1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used.
2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products.
3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you.
For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.