| | Class 2 Device Recall RTC 25C Inline Aerosol Tee Adapter |  |
| Date Initiated by Firm | November 13, 2013 |
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| Date Posted | December 29, 2013 |
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| Recall Status1 |
Terminated 3 on July 09, 2014 |
| Recall Number | Z-0606-2014 |
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| Recall Event ID |
66902 |
| Product Classification |
Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
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| Product | RTC 25-C Inline Aerosol Tee Adapter.
Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit. |
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| Code Information |
multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013. |
| FEI Number |
2518436
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Recalling Firm/
Manufacturer |
Instrumentation Industries Inc
2990 Industrial Blvd
Bethel Park PA 15102-2536
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| For Additional Information Contact | Customer Support
412-854-1133 |
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Manufacturer Reason
for Recall | Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. |
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FDA Determined
Cause 2 | Labeling Change Control |
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| Action | A recall notification letter, dated November 13, 2013, was sent to Users. |
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| Quantity in Commerce | 220 |
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| Distribution | Nationwide Distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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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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