PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported December 28, 2016

AbbVie PEG Kit 20 FR

AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.

Recall #
Z-0786-2017
Affected scope
541 units
Initiated
November 22, 2016
Compiled from official public sources by the editorial team.
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AbbVie Inc. recalled AbbVie PEG Kit 20 FR - a moderate-severity action.

AbbVie PEG Kit 20 FR was recalled by AbbVie Inc. in December 28, 2016. Reason: AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnect…. Check the official notice for the remedy. Verify recall #Z-0786-2017 with the FDA Devices before acting.

The recall

AbbVie Inc. issued this moderate-severity FDA Devices recall-AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnect….

Moderate
severity level
541 units
affected scope
Class II
classification
December 28, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0786-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0786-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on November 22, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. AbbVie Inc. is listed as the recalling firm, operating out of North Chicago, IL. Federal records list the affected scope as 541 units.

The documented reason for this recall is: AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors. Distribution data in the federal record shows the product reached: U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

541 units

Related Recalls

6

3 from same agency

Product description

AbbVie PEG Kit 20 FR

Reason for recall

AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-0786-2017
Date reported December 28, 2016
Date initiated November 22, 2016
Recalling firm AbbVie Inc.
Firm location North Chicago, IL
Affected scope 541 units
Distribution U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

541 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0786-2017) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
AbbVie PEG Kit 20 FR. Recalled by AbbVie Inc.. Units affected: 541 units.
Why was this product recalled?
AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0786-2017.
Where was the recalled product distributed?
Distribution: U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-0786-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 28, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.