Medical Device
Manufacturing
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Z-0696-2016Class II

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

Global Healthcare, Inc. / initiated 2016-01-06 / Terminated / root cause: manufacturing process

Global Healthcare Inc began a recall of ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China on . FDA classified it as Class II and gives the reason as "Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0696-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Global Healthcare, Inc.
Product
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
Product code
FPA Set, Administration, Intravascular
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.
Root cause tag
manufacturing process
FDA 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 in commerce
2,000 cases (100 individual units per case)
Distribution
US Distribution to state of: GA only.
Product codes and lots
Lot Number 1505201

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0696-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0696-2016Class IITerminatedVoluntary: Firm initiated