Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 31, 2017
CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Corpak MedSystems, Inc. recalled CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for deliver… - a moderate-severity action.
CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for deliver… was recalled by Corpak MedSystems, Inc. in May 31, 2017. Reason: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may br…. Check the official notice for the remedy. Verify recall #Z-2163-2017 with the FDA Devices before acting.
The recall
Corpak MedSystems, Inc. issued this moderate-severity FDA Devices recall-Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may br….
- Moderate
- severity level
- Class II
- classification
- May 31, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2163-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2163-2017) was formally reported on May 31, 2017, with the manufacturer initiating the action on February 3, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Corpak MedSystems, Inc. is listed as the recalling firm, operating out of Buffalo Grove, IL. Federal records list the affected scope as 8 cases (2 units per case).
The documented reason for this recall is: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. Distribution data in the federal record shows the product reached: Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand. 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
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.
Affected scope
8 cases (2 units per case)
Related Recalls
6
3 from same agency
Product description
CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Reason for recall
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2163-2017 |
| Date reported | May 31, 2017 |
| Date initiated | February 3, 2017 |
| Recalling firm | Corpak MedSystems, Inc. |
| Firm location | Buffalo Grove, IL |
| Affected scope | 8 cases (2 units per case) |
| Distribution | Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2163-2017) 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? ▼
CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.. Recalled by Corpak MedSystems, Inc.. Units affected: 8 cases (2 units per case).
Why was this product recalled? ▼
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2017. Severity: Moderate. Recall number: Z-2163-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2163-2017) 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.
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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 May 31, 2017. 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.