Public recall detail

Mic-Peg Kit

medium
Recall Safety notice
Quick summary

Quick summary: Mic-Peg Kit.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Mic-Peg Kit.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAvanos Medical, Inc.
ProductMic-Peg Kit
IssueMedical devices - Manufacturing defect
Recall classType II
IdentificationRA-63789

Affected products

ProductMic-Peg Kit
Lot30135103
Model7640-20
Serial number30135103
DescriptionMic-Peg Kit
ProductMic-Peg Kit
Lot30132546
Model8640-20
Serial number30132546
DescriptionMic-Peg Kit
ProductMic-Peg Kit
Lot30132545
Serial number30132545
DescriptionMic-Peg Kit
ProductMic-Peg Kit
Lot30132544
Serial number30132544
DescriptionMic-Peg Kit
ProductMic-Peg Kit
Lot30132543
Serial number30132543
DescriptionMic-Peg Kit
ProductMic-Peg Kit
Lot30129345
Serial number30129345
DescriptionMic-Peg Kit
ProductMic-Peg Kit
Lot30116959
Serial number30116959
DescriptionMic-Peg Kit

Issue

The External Retention Bolster contained in some of the mic* standard Percutaneous Endoscopic Gastrostomy Peg Kit - 20 FR - pull has a larger diameter (24FR) than the tube (20FR). As a result, the Bolster is too large to hold the Peg Tube to the correct tension which keeps it in place. Recall start date: December 22nd, 2021.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices
CompaniesPublished by Health Canada
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63789
Background{}
CompaniesPublished by Health Canada
AudiencesGeneral public Health professionals Hospitals
Source updated2022-01-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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