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U.S. Department of Health and Human Services

Class 2 Device Recall Flexible Support Arm Assembly

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 Class 2 Device Recall Flexible Support Arm Assemblysee related information
Date Initiated by FirmOctober 14, 2005
Date PostedJanuary 24, 2006
Recall Status1 Terminated 3 on May 09, 2006
Recall NumberZ-0427-06
Recall Event ID 33923
Product Classification Support, Breathing Tube - Product Code JAY
ProductFlexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30
Code Information Lot numbers PO902505 and PO900805
FEI Number 2518436
Recalling Firm/
Manufacturer		 Instrumentation Industries Inc
2990 Industrial Blvd
Bethel Park PA 15102-2536
For Additional Information ContactSusan Mantia
412-854-1133 Ext. 433
Manufacturer Reason
for Recall		potential for the flexible tube portion of the assembly to become brittle and break
FDA Determined
Cause 2		Other
ActionAll customers (and/or end-users) were notified on October 14 and 17, 2005 by telephone. Formal notification letters were sent (certified) to each customer (and/or end-user) on October 17 and 18, 2005.
Quantity in Commerce22 units
DistributionThe products were shipped to medical facilities in FL, NY, and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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