Device Recall (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile 의 리콜

Recall

70721

Class 2

Z-1347-2015

2015-03-10

2015-03-27

Terminated

United States

2017-01-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134555

This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 cfr 801.437; it does not contain caution: the packaging of this product contains natural rubber latex which may cause allergic reactions.

The firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: recall@ecolab.com RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email; customerservice@microtekmed.com.