Device Recall Tegaderm 의 리콜

Recall

73237

Class 2

Z-1036-2016

2016-02-03

Terminated

United States

2016-06-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143609

Misbranding; due to the presence of chg in the tegaderm picc/cvc dressing change convenience kit, which is not identified on the exterior labeling.

Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting quality@owens-minor.com . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630.