| Date Initiated by Firm | April 17, 2003 |
|---|
| Date Posted | May 15, 2003 |
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| Recall Status1 |
Terminated 3 on August 20, 2003 |
| Recall Number | Z-0837-03 |
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| Recall Event ID |
26140 |
| 510(K)Number | K013394 |
|---|
| Product Classification |
Set, Administration, Intravascular - Product Code FPA
|
| Product | SHPI LIftLoc Safety Infusion Sets |
|---|
| Code Information |
Product Code - Lot #: 0661934- 36ANHP01; 0662034 - 36ANHP02; 0662234 - 36ANHO03; 0661910 -36ANHP04; 0661915 - 36ANHP04; 0661915 -36ANHP06; 0662015 - 36ANHO7; 0662215 -36ANHP08; 0662010- 36ANHP09; 0641910 -36ANHP10; 0642234 -36ANHP11; 0642210 - 36ANHP12; 0641934 -36ANHP13; 0642034 -36ANHP14; 0642010 -36ANHP15; 0614915 -36ANHP16; 0642015 -36ANHP17; 0642210 -36ANHP19; 0642234 -36ANHP20; 0641910 -36ANHP21. |
Recalling Firm/
Manufacturer |
Specialized Health Products, Inc.
585 West 500 South
Bountiful UT 84010
|
| For Additional Information Contact |
801-298-3360 |
|---|
Manufacturer Reason
for Recall | Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | The single consignee (BAS) was notified by lettter on 4/14/03. |
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| Quantity in Commerce | 2240 units |
|---|
| Distribution | Utah. |
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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.
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| 510(K) Database | 510(K)s with Product Code = FPA
|
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