| Date Initiated by Firm | October 14, 2019 |
|---|
| Create Date | December 10, 2019 |
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| Recall Status1 |
Terminated 3 on July 19, 2021 |
| Recall Number | Z-0664-2020 |
|---|
| Recall Event ID |
84272 |
| 510(K)Number | K111576 |
|---|
| Product Classification |
Generator, lesion, radiofrequency - Product Code GXD
|
| Product | Radiofrequency Grounding Pad, REF RF-DGP-L |
|---|
| Code Information |
UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021 |
Recalling Firm/
Manufacturer |
Abbott Medical
5050 Nathan Ln N
Plymouth MN 55442-3209
|
| For Additional Information Contact | Mr. Brent Tippen
512-286-4217 |
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Manufacturer Reason
for Recall | Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating. |
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FDA Determined
Cause 2 | Process control |
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| Action | The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative. |
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| Quantity in Commerce | 8940 devices |
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| Distribution | nationwide |
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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 = GXD
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