Avanos Medical, Inc. Recall 89290
Description: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Avanos Medical, Inc. Recall 89290 Information
Status | Terminated |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0565-2022 |
Event ID | 89290 |
Event Description | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Chile. |
Quantity | 2652 units |
Recall Reason | The External Retention Bolster contained in the kit may be a larger diameter than the tube. |
Device Classification | 20220216 |
Device Code Info | 1) Code 7160-20, Lots 30116959, 30132543, 30132545, and 30132546 2) Code 7640-20, Lots 30129345 |
Center Classification Date | 20220207 |
Recall Initiation Date | 20211222 |
Recalling Firm | Avanos Medical, Inc. |
Initial Notification | |
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