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Presource procedure packs

Official notice

30 May 2022

Last checked

30 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Presource procedure packs. Cardinal Health was recently informed of a field action correction from Becton Dickinson (bd) concerning the manometer bottom assembly. The correction is being issued due to complaints and mating issues from the manometer. After reviewing the potential impact of this recall on Presource Procedure Packs, Cardinal Health is initiating an urgent medical device correction on specific lots of Presource packs produced containing the affected bd manometer bottom assembly component and lot number(s). Recall start date: May 20, 2022 Published 2022-05-30.

What to do now

Quarantine affected inventory, affix supplied warning label (to discard component), return reply form.

Recall number

64208

Official notice

2022-05-30

The hazard

Cardinal Health was recently informed of a field action correction from Becton Dickinson (bd) concerning the manometer bottom assembly. The correction is being issued due to complaints and mating issues from the manometer. After reviewing the potential impact of this recall on Presource Procedure Packs, Cardinal Health is initiating an urgent medical device correction on specific lots of Presource packs produced containing the affected bd manometer bottom assembly component and lot number(s). Recall start date: May 20, 2022

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64208

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Affected products

Product 1

Affected products - Presource Procedure Packs, Lot or Serial number - 656401 795238 718556 713939 711087 631781 696297 786839 715657, Model or Catalogue number - SAN30LPGBB SBA30LBNHD SBA30LBYCB

Risk / hazard

Cardinal Health was recently informed of a field action correction from Becton Dickinson (bd) concerning the manometer bottom assembly. The correction is being issued due to complaints and mating issues from the manometer. After reviewing the potential impact of this recall on Presource Procedure Packs, Cardinal Health is initiating an urgent medical device correction on specific lots of Presource packs produced containing the affected bd manometer bottom assembly component and lot number(s). Recall start date: May 20, 2022

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Cardinal Health, Presource Procedure Packs.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64208

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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