| | Class 2 Device Recall MSIEpiDermGlu |  |
| Date Initiated by Firm | July 03, 2003 |
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| Date Posted | July 15, 2003 |
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| Recall Status1 |
Terminated 3 on January 23, 2004 |
| Recall Number | Z-1018-03 |
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| Recall Event ID |
26613 |
| Product Classification |
unknown device name - Product Code MPN--
|
| Product | MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case; Manufactured by Medisav Services Inc. (MSI), 56 Elson Street, Markham, Ontario L3S 1Y7 Canada |
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| Code Information |
Product #51002, all lots |
| FEI Number |
3003812831
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Recalling Firm/
Manufacturer |
Elite Medical Group
2907 Gill Street
Bloomington IL 61704
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| For Additional Information Contact |
866-423-0977 |
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Manufacturer Reason
for Recall | The liquid tissue adhesive was marketed without FDA pre-market clearance. |
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FDA Determined
Cause 2 | Other |
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| Action | Recalled by letter dated 7/2/03, informing the accounts that the skin adhesive had not been approved for marketing in the United States and that they should return the product to Elite Medical. |
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| Quantity in Commerce | 129 cases |
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| Distribution | Illinois, Tennessee, Kansas, Kentucky, Maryland and Missouri |
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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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