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FDA Medical Device Recalls (openFDA)

Global Healthcare Inc: ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

Recall number
Z-0696-2016
Recalling firm
Global Healthcare Inc
Product
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
Status
Terminated
Initiated
2016-01-06
Posted
2016-02-03
Terminated
2016-03-25
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 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.
Quantity
2,000 cases (100 individual units per case)
Distribution
US Distribution to state of: GA only.
Lot, serial or model codes
Lot Number 1505201
510(k) numbers
["K083687"]
PMA numbers
not on file
Product code
FPA
Firm FEI
1000140469
Firm city
Alpharetta
Firm state
GA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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