Recall Z-0696-2016 ยท FPA Set, Administration, Intravascular
Global Healthcare Inc
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
| Date | Feb 3, 2016 (initiated Jan 6, 2016) |
| Status | Terminated |
| Reason | Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard. |
| Root cause | Nonconforming Material/Component |
| Action | Global Healthcare sent an "Urgent: DEVICE RECALL" letter dated January 6, 2015 to its Customer by email. The letter described the product, problem and actions to be taken. The customer was instructed to immediately examine its inventory to determine if you have any of the Model ET-20 on hand; if so, immediately discontinue distributing product; and complete and return the Distributor Device Recall Response Form by email. Additionally, if you have further distributed any of the product, immediately contact your accounts; advise them of recall situation and have them return their outstandin |
| Quantity | 2,000 cases (100 individual units per case) |
| Distribution | US Distribution to state of: GA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083687 | BAIXIN INTRAVASCULAR ADMINISTRATION SET Anhui Kangda Medical Products Co., Ltd., Jun 11, 2009 |