| Date Initiated by Firm | June 11, 2020 |
|---|
| Create Date | July 04, 2020 |
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| Recall Status1 |
Terminated 3 on January 25, 2021 |
| Recall Number | Z-2499-2020 |
|---|
| Recall Event ID |
85847 |
| 510(K)Number | K072657 |
|---|
| Product Classification |
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
|
| Product | PORT-A-CATH II POWER P.A.C. Low Profile" system. |
|---|
| Code Information |
Lot 3921849. |
Recalling Firm/
Manufacturer |
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
|
| For Additional Information Contact | Dave Halverson
763-383-3072 |
|---|
Manufacturer Reason
for Recall | Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter. |
|---|
| Quantity in Commerce | 46 kits |
|---|
| Distribution | Domestic Distribution: AR, CT, MS,TN,TX |
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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 = LJT
|
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