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Avanos Medical, Inc. Recall 89290

Description: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

Avanos Medical, Inc. Recall 89290 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0566-2022
Event ID89290
Event DescriptionMIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada and Chile.
Quantity692 units
Recall ReasonThe External Retention Bolster contained in the kit may be a larger diameter than the tube.
Device Classification20220216
Device Code Info1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544
Center Classification Date20220207
Recall Initiation Date20211222
Recalling FirmAvanos Medical, Inc.
Initial Notification E-Mail
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