Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2018
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Arrow International Inc recalled 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2 - a moderate-severity action.
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2 was recalled by Arrow International Inc in September 26, 2018. Reason: The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may …. Check the official notice for the remedy. Verify recall #Z-3200-2018 with the FDA Devices before acting.
The recall
Arrow International Inc issued this moderate-severity FDA Devices recall-The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may ….
- Moderate
- severity level
- Class II
- classification
- September 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3200-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3200-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on July 17, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Arrow International Inc is listed as the recalling firm, operating out of Reading, PA. Federal records list the affected scope as 1257 total.
The documented reason for this recall is: The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a … Distribution data in the federal record shows the product reached: The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.. 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 - 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 - 40,422 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
1257 total
Related Recalls
6
0 from same agency
Product description
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Reason for recall
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3200-2018 |
| Date reported | September 26, 2018 |
| Date initiated | July 17, 2018 |
| Recalling firm | Arrow International Inc |
| Firm location | Reading, PA |
| Affected scope | 1257 total |
| Distribution | The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA. |
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-3200-2018) 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? ▼
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2. Recalled by Arrow International Inc. Units affected: 1257 total.
Why was this product recalled? ▼
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3200-2018.
Where was the recalled product distributed? ▼
Distribution: The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3200-2018) 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 September 26, 2018. 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.