ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
FDA device recall Z-0696-2016 · posted 2016-02-03 · Terminated
Recall details
- Recalling firm
- Global Healthcare Inc
- Reason for recall
- Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.
- Action taken
- 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 outstanding recalled stocks to you. Any returned product will be destroyed by the distributor upon receipt of all affected product. If you require further assistance, please call 770-522-7520.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2,000 cases (100 individual units per case)
- Distribution
- US Distribution to state of: GA only.
- Date initiated
- 2016-01-06
- Date posted
- 2016-02-03
- Date terminated
- 2016-03-25
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAIXIN INTRAVASCULAR ADMINISTRATION SET (K083687) | Anhui Kangda Medical Products Co., Ltd. | 2009-06-11 |