| Date Initiated by Firm | February 18, 2010 |
|---|
| Date Posted | April 20, 2010 |
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| Recall Status1 |
Terminated 3 on April 20, 2010 |
| Recall Number | Z-1422-2010 |
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| Recall Event ID |
54769 |
| 510(K)Number | K040235 |
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| Product Classification |
brain oxygen probe - Product Code GWM
|
| Product | Integra, Licox Ref 1P2.P;
Brain PMO-Probe Kit
Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes,
REF CC1/P1 Combined Oxygen & Temperature Probe.
Contents Sterile and Non-Pyrogenic if package is unopened and undamaged. |
|---|
| Code Information |
Catalog number CC1P1, Serial number SN 776; Lot number 160110A |
Recalling Firm/
Manufacturer |
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
|
| For Additional Information Contact | Lauren Moose
609-936-6876 |
|---|
Manufacturer Reason
for Recall | One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center. |
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FDA Determined
Cause 2 | Process control |
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| Action | An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter. |
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| Quantity in Commerce | 1 |
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| Distribution | One hospital in Omaha, NE. |
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| Total Product Life Cycle | TPLC 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.
|
| 510(K) Database | 510(K)s with Product Code = GWM
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